Vascular access ports and related methods

ABSTRACT

Ports for accessing vessels within a patient include passageways that can guide needles or other access devices directly into the vessels. The ports can be implanted subcutaneously within a patient. Some ports may be used in the creation and use of vascular access buttonholes.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of prior U.S. patentapplication Ser. No. 12/697,167, filed Jan. 29, 2010, titled VASCULARACCESS PORTS AND RELATED METHODS, and is a continuation-in-part of priorU.S. patent application Ser. No. 12/697,192, filed Jan. 29, 2010, titledSUBCUTANEOUS VASCULAR ACCESS PORTS AND RELATED SYSTEMS AND METHODS; eachof the foregoing applications claims the benefit under 35 U.S.C. §119(e)of U.S. Provisional Patent Application No. 61/148,372, titled VASCULARACCESS METHODS, APPARATUS AND SYSTEMS, filed on Jan. 29, 2009, and ofU.S. Provisional Patent Application No. 61/229,023, titled SURGICALLYIMPLANTED DIRECT VASCULAR ACCESS PORT METHOD AND APPARATUS, filed onJul. 28, 2009. The entire contents of each of the foregoing applicationsare hereby incorporated by reference herein.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

The invention was made with support from the U.S. Government under GrantNo. SBIR R44 CA 139608, which was awarded by the National Institutes ofHealth. The U.S. Government has certain rights in the invention.

TECHNICAL FIELD

The present disclosure relates to subcutaneous vascular access ports andrelated systems and methods.

BRIEF DESCRIPTION OF THE DRAWINGS

The written disclosure herein describes illustrative embodiments thatare non-limiting and non-exhaustive. Reference is made to certain ofsuch illustrative embodiments that are depicted in the figures, inwhich:

FIG. 1 is a perspective view of an embodiment of a vascular access port;

FIG. 2 is a front elevation view thereof;

FIG. 3 is a rear elevation view thereof;

FIG. 4 is a top plan view thereof;

FIG. 5 is a bottom plan view thereof;

FIG. 5A is a partial bottom plan view thereof;

FIG. 5B is a partial bottom plan view of another embodiment of avascular access port;

FIG. 5C is a partial bottom plan view of yet another embodiment of avascular access port;

FIG. 6 is a right side elevation view of the vascular access port ofFIG. 1, wherein a left side elevation view is a mirror image of theright side elevation view;

FIG. 7 is a cross-sectional view of the vascular access port of FIG. 1taken along the view line 7-7 in FIG. 2;

FIG. 8 is a perspective view of the vascular access port of FIG. 1coupled with a vessel, which is shown in a perspective partial cutawayview;

FIG. 9A is a perspective view of a stage of an illustrative method ofimplanting an embodiment of a vascular access port in a patientdepicting the creation of an incision;

FIG. 9B is a perspective view of another stage of the method of FIG. 9Ain which a vessel is exposed;

FIG. 9C is a perspective view of another stage of the method of FIG. 9Ain which an attachment is made between the vascular access port and thevessel;

FIG. 9D is a perspective view of another stage of the method of FIG. 9Ain which additional attachments have been made between the vascularaccess port and the vessel;

FIG. 9E is a perspective view of another stage of the method of FIG. 9Ain which the incision has been closed;

FIG. 10A is a perspective view of a stage of another illustrative methodof implanting an embodiment of a vascular access port depicting thecreation of an incision in the skin of a patient;

FIG. 10B is a perspective view of another stage of the method of FIG.10A in which adventitia of a vessel is isolated;

FIG. 10C is a perspective view of another stage of the method of FIG.10A in which in incision is made in the adventitia;

FIG. 10D is a perspective view of another stage of the method of FIG.10A in which a pocket is formed in the adventitia;

FIG. 10E is a perspective view of another stage of the method of FIG.10A in which an embodiment of a vascular access port is inserted intothe pocket;

FIG. 10F is a perspective view of another stage of the method of FIG.10A in which attachments have been made between the vascular access portand the vessel;

FIG. 10G is a perspective view of another stage of the method of FIG.10A in which the incision in the skin of the patient has been closed;

FIG. 11A is a cross-sectional view of a palpation stage of anillustrative method relating to the creation and use of a buttonholeaccess site to access a lumen of a vessel;

FIG. 11B is a cross-sectional view of another stage of the method ofFIG. 11A in which a needle having a sharp tip is inserted into the lumenof the vessel via an embodiment of a vascular access port;

FIG. 11C is a cross-sectional view of another stage of the method ofFIG. 11A in which pressure is applied to the skin of the patient;

FIG. 11D is a cross-sectional view of another stage of the method ofFIG. 11A in which an insertion tract and a buttonhole access site havebeen formed;

FIG. 11E is a cross-sectional view of another stage of the method ofFIG. 11A in which a needle having a blunt tip is inserted into the lumenof the vessel via the insertion tract, the vascular access port, and thebuttonhole access site;

FIG. 12 is a cross-sectional view of a stage of another illustrativemethod relating to the creation and use of a buttonhole access site toaccess a lumen of a vessel;

FIG. 13 is a bottom plan view of a filleted vessel that bears anembodiment of a buttonhole access site that has been created via anembodiment of a vascular access port;

FIG. 14A is a perspective view of an embodiment of a vascular accesssystem that can be used for hemodialysis;

FIG. 14B is a perspective view of another embodiment of a vascularaccess system that can be used for hemodialysis;

FIG. 15 is a perspective view of an embodiment of a vascular accesssystem that can be used for the external treatment of blood;

FIG. 16A is a perspective view of another embodiment of a vascularaccess port;

FIG. 16B is a rear elevation view thereof;

FIG. 16C is a front elevation view thereof;

FIG. 16D is a top plan view thereof;

FIG. 16E is a bottom plan view thereof;

FIG. 16F is a right side elevation view thereof, wherein a left sideelevation view thereof is a mirror image of the right side elevationview;

FIG. 16G is a cross-sectional view thereof;

FIG. 17A is a perspective view of another embodiment of a vascularaccess port;

FIG. 17B is a perspective view of the vascular access port of FIG. 17Acoupled to a vessel;

FIG. 18 is a perspective view of an embodiment of a vascular accesssystem;

FIG. 19 is a perspective view of another embodiment of a vascular accessport;

FIG. 20 is a cross-sectional view of another embodiment of a vascularaccess port;

FIG. 21A is a perspective view of another embodiment of a vascularaccess port;

FIG. 21B is a rear elevation view thereof;

FIG. 21C is a front elevation view thereof;

FIG. 21D is a top plan view thereof;

FIG. 21E is a bottom plan view thereof;

FIG. 21F is a right side elevation view thereof, wherein a left sideelevation view thereof is a mirror image of the right side elevationview;

FIG. 21G is a cross-sectional view thereof;

FIG. 22A is a perspective view of another embodiment of a vascularaccess port;

FIG. 22B is a front elevation view thereof;

FIG. 22C is a rear elevation view thereof;

FIG. 22D is a top plan view thereof;

FIG. 22E is a bottom plan view thereof;

FIG. 22F is a right side elevation view thereof, wherein a left sideelevation view thereof is a mirror image of the right side elevationview;

FIG. 22G is a cross-sectional view thereof;

FIG. 23A is a cross-sectional view of a palpation stage of anillustrative method relating to the creation and use of a buttonholeaccess site to access a lumen of a vessel;

FIG. 23B is a cross-sectional view of another stage of the method ofFIG. 23A in which a needle having a sharp tip is inserted into the lumenof the vessel via an embodiment of a vascular access port;

FIG. 23C is a cross-sectional view of another stage of the method ofFIG. 23A in which pressure is applied to the skin of the patient;

FIG. 23D is a cross-sectional view of another stage of the method ofFIG. 23A in which a buttonhole access site has been formed;

FIG. 23E is a cross-sectional view of another stage of the method ofFIG. 23A in which a needle having a blunt tip is inserted into the lumenof the vessel via the vascular access port and the buttonhole accesssite;

FIG. 24A is a perspective view of another embodiment of a vascularaccess port;

FIG. 24B is a front elevation view thereof;

FIG. 24C is a rear elevation view thereof;

FIG. 24D is a top plan view thereof;

FIG. 24E is a bottom plan view thereof;

FIG. 24F is a right side elevation view thereof, wherein a left sideelevation view thereof is a mirror image of the right side elevationview;

FIG. 24G is a cross-sectional view thereof;

FIG. 25A is a perspective view of another embodiment of a vascularaccess port;

FIG. 25B is a front elevation view thereof;

FIG. 25C is a rear elevation view thereof;

FIG. 25D is a top plan view thereof;

FIG. 25E is a bottom plan view thereof;

FIG. 25F is a right side elevation view thereof, wherein a left sideelevation view thereof is a mirror image of the right side elevationview;

FIG. 25G is a cross-sectional view thereof;

FIG. 26A is a perspective view of another embodiment of a vascularaccess port;

FIG. 26B is a front elevation view thereof;

FIG. 26C is a rear elevation view thereof;

FIG. 26D is a top plan view thereof;

FIG. 26E is a bottom plan view thereof;

FIG. 26F is a right side elevation view thereof, wherein a left sideelevation view thereof is a mirror image of the right side elevationview;

FIG. 26G is a cross-sectional view thereof;

FIG. 27A is a perspective view of another embodiment of a vascularaccess port;

FIG. 27B is a front elevation view thereof;

FIG. 27C is a rear elevation view thereof;

FIG. 27D is a top plan view thereof;

FIG. 27E is a bottom plan view thereof;

FIG. 27F is a right side elevation view thereof, wherein a left sideelevation view thereof is a mirror image of the right side elevationview;

FIG. 27G is a cross-sectional view thereof;

FIG. 28A is a perspective view of another embodiment of a vascularaccess port;

FIG. 28B is a front elevation view thereof;

FIG. 28C is a rear elevation view thereof;

FIG. 28D is a top plan view thereof;

FIG. 28E is a bottom plan view thereof;

FIG. 28F is a right side elevation view thereof, wherein a left sideelevation view thereof is a mirror image of the right side elevationview;

FIG. 28G is a cross-sectional view thereof;

FIG. 29A is a top perspective view of another embodiment of a vascularaccess port;

FIG. 29B is a bottom perspective view thereof;

FIG. 29C is a front elevation view thereof;

FIG. 29D is a rear elevation view thereof;

FIG. 29E is a top plan view thereof;

FIG. 29F is a bottom plan view thereof;

FIG. 29G is a right side elevation view thereof, wherein a left sideelevation view thereof is a mirror image of the right side elevationview;

FIG. 29H is a cross-sectional view thereof;

FIG. 30A is a perspective view of another embodiment of a vascularaccess port;

FIG. 30B is a cross-sectional view thereof;

FIG. 30C is a bottom plan view thereof;

FIG. 31A is a perspective view of another embodiment of a vascularaccess port;

FIG. 31B is a cross-sectional view thereof;

FIG. 31C is a bottom plan view thereof;

FIG. 32A is a perspective view of another embodiment of a vascularaccess port;

FIG. 32B is a side elevation view thereof;

FIG. 33C is a cross-sectional view thereof;

FIG. 33A is a perspective view of another embodiment of a vascularaccess port;

FIG. 33B is a cross-sectional view thereof;

FIG. 34A is a perspective view of another embodiment of a vascularaccess port;

FIG. 34B is a right side elevation view thereof, wherein a left sideelevation view thereof is a mirror image of the right side elevationview;

FIG. 34C is a front elevation view thereof;

FIG. 34D is a rear elevation view thereof;

FIG. 34E is a top plan view thereof;

FIG. 34F is a bottom plan view thereof;

FIG. 34G is a cross-sectional view thereof;

FIG. 35A is a perspective view of another embodiment of a vascularaccess port;

FIG. 35B is a right side elevation view thereof, wherein a left sideelevation view thereof is a mirror image of the right side elevationview;

FIG. 35C is a front elevation view thereof;

FIG. 35D is a rear elevation view thereof;

FIG. 35E is a top plan view thereof;

FIG. 35F is a bottom plan view thereof;

FIG. 36A is a perspective view of another embodiment of a vascularaccess port;

FIG. 36B is a right side elevation view thereof, wherein a left sideelevation view thereof is a mirror image of the right side elevationview;

FIG. 36C is a front elevation view thereof;

FIG. 36D is a rear elevation view thereof;

FIG. 36E is a bottom plan view thereof;

FIG. 36F is a top plan view thereof;

FIG. 37A is a perspective view of another embodiment of a vascularaccess port;

FIG. 37B is a right side elevation view thereof, wherein a left sideelevation view thereof is a mirror image of the right side elevationview;

FIG. 37C is a front elevation view thereof;

FIG. 37D is a rear elevation view thereof;

FIG. 37E is a top plan view thereof;

FIG. 37F is a bottom plan view thereof; and

FIG. 38 is a perspective view of another embodiment of a vascular accessport.

DETAILED DESCRIPTION

Certain embodiments of vascular access ports described herein areconfigured to be implanted subcutaneously in a patient for relativelylong or indefinite periods. The vascular access ports can be implantedin any suitable manner and can be substantially fixed relative to avessel wall once implanted. For example, in some implantation methods, abottom surface of a vascular access port placed in contact with thetunica adventitia of a vessel and the port is secured to the vessel viaone or more sutures that extend through at least a portion of everylayer of the vessel. In further embodiments, a portion of the tunicaadventitia is separated or removed from a blood vessel such that thebottom surface of a port is relatively close to the tunica media layerof the blood vessel, and the port is secured to the vessel via one ormore sutures that extend through at least a portion of the tunicaadventitia layer and substantially entirely through the media and thetunica intima layers. In some embodiments, the surface of the port thatcontacts the vessel wall can comprise an opening through which an accessdevice, such as a needle, can be inserted into a lumen of the bloodvessel. The vascular access ports can be well-suited for buttonholecannulation techniques in which buttonhole access sites are created invessel walls and/or are used to access the vessels. The term“buttonhole” is used herein in its ordinary sense in the field ofvascular access (e.g., in the field of hemodialysis), particularly inthe context of cannulation techniques, and the term can includesingle-site cannulation holes that are approximately the same size asaccess devices that are inserted therethrough (e.g., needles or othercannulation devices), and that can permit relatively easy insertion ofthe access devices as compared with other areas along a vessel wall.Similarly, the ports can be well-suited for the creation and/or use oftracts through the skin of a patient through which the buttonholes canbe repeatedly accessed. These and other features and advantages ofvarious embodiments of vascular access ports, of systems that employ theports, and of methods of implanting and using the ports will be apparentfrom the disclosure herein.

FIGS. 1-7 illustrate an embodiment of a vascular access port 100. Thevascular access port 100 includes a base 102 and a body 104. In theillustrated embodiment, the base 102 and the body 104 are integrallyformed as a unitary piece, and the body 104 extends away from the base102. The base 102 is elongated in a longitudinal direction LONG. Inparticular, the illustrated base 102 defines a substantially rectangularperimeter 106 that extends a greater distance in the longitudinaldirection LONG than it does in a transverse or lateral direction LAT(see, e.g., FIG. 5). The edges and corners of the rectangular perimeter106 can be rounded, or radiused, which can prevent trauma to surroundingtissue when the vascular access port 100 is implanted.

In the drawings, the longitudinal and lateral directions LONG, LAT arerepresented by perpendicular axes. A vertical direction VERT isrepresented by a third axis that is perpendicular to each of thelongitudinal and lateral axes. In the illustrated embodiment, thelongitudinal direction LONG corresponds with a direction in which alongitudinal axis of a vessel extends when the port 100 is attached tothe vessel (see FIG. 8). The three sets of mutually perpendicular axesare provided for illustration, and are not intended to limit thepotential orientations of the port 100. For example, although the term“vertical” is used with respect to the vertical direction, this termdoes not imply any preferred gravitational orientation of the port 100.By way of illustration, in some embodiments, the port 100 may be fixedlyattached to a vessel in an arm or a leg of a patient such that thevertical direction VERT relative to the port may assume any orientationrelative to a true or gravitationally-based vertical direction dependingon the position of the arm or the leg.

The base 102 can include a base surface or bottom surface 108 that isconfigured to face a vessel when the vascular access port 100 is coupledto the vessel. The bottom surface 108 can be configured to conform to acontour of a wall of the vessel. For example, the bottom surface 108 ofthe base 102 can be bowed in the lateral direction and can have a radiusof curvature that is substantially the same as a radius of curvature ofan outer surface of a vessel to which the vascular access port 100 is tobe attached. Stated otherwise, as shown in FIGS. 2 and 3, the base 102can extend from a central position both outwardly in the lateraldirection and downwardly in the vertical direction so as to define abowed or arched shape such that the bottom surface 108 of the base 102can conform to an outer surface of a vessel. The bowed bottom surface108 can define a cavity 110 into which at least a portion of acircumference of a vessel can be received. In the illustratedembodiment, the width and the curvature of the bottom surface 108 aresuch that the cavity 110 is sized to receive a substantial portion ofthe circumference of a vessel therein. Such a configuration can permitthe bottom surface 108 to form a stable contact with the vessel. Othersuitable arrangements are also possible, as discussed below.

The base 102 can include one or more connection flanges 112 that extendabout a least a portion of a periphery of the base 102. In theillustrated embodiment, a first connection flange 112 extends about afront end of the base 102 and a second connection flange 112 is at aback end of the base 102. One or more attachment channels or attachmentpassages 114 can extend through the connection flanges 112. Theattachment passages 114 can be configured to permit one or more ties orattachment devices 116 to extend therethrough so as to attach thevascular access port 100 to a vessel (see, e.g., FIGS. 8, 9C, 10F, 11A,and 12), as discussed further below. Any suitable attachment devices 116may be used, such as one or more sutures, pinch rings, hooks, or wires.Accordingly, in some embodiments, one or more of the attachment passages114 may be referred to as suture holes. As further discussed below, inthe illustrated embodiment, the base 102 includes a centrally situatedattachment passage 114 at each of the front and rearward ends thereof.

The body 104 can extend vertically upward from the base 102. In theillustrated embodiment, the body 104 rises upwardly along a centralvertical-longitudinal plane 120 (see FIGS. 2 and 4) of the vascularaccess port 100. With reference to FIG. 4, the body 104 can expandlaterally outward from the central vertical-longitudinal plane 120 andcan widen in a rearward direction. Additionally, as shown in FIGS. 3, 4,and 6, a pinnacle region 122 of the body 104 can be positioned along thecentral vertical-longitudinal plane 120 and at approximately alongitudinal center of the body 104. As previously mentioned, in theillustrated embodiment, the body 104 is integrally formed with the base102. The port 100 thus may seamlessly or smoothly transition from thebase 102 to the body 104. In other embodiments, the base 102 and thebody 104 may comprise separate pieces that are attached to each other.

It is noted that directional terms, such as bottom, front, and rearward,are used relative to the orientation of the vascular access port 100shown in FIG. 1. Such directional terms are not intended to limit thepossible orientations of the vascular access port 100 within a patient.For example, in some embodiments, the front end of the vascular accessport 100 may be oriented downstream from the rearward end thereof whenthe port 100 is coupled to a vessel (e.g., may be used for antegradeaccess to the vessel), whereas in other embodiments, the front end maybe oriented upstream from the rearward end (e.g., may be used forretrograde access to the vessel).

A guidance passageway 130 can extend through the body 104. In theillustrated embodiment, the guidance passageway 130 includes a funnelregion 132 and a channel 134. The funnel region 132 defines a relativelylarge entry mouth 136, which extends about or circumscribes the proximalend or proximal opening thereof, and the funnel region 132 narrows fromthe entry mouth 136 in a forward and downward direction. In theillustrated embodiment, a forward end of the funnel region 132transitions into the channel 134. The funnel region 132 can include abase surface 138 that projects rearwardly from the channel 134 and thatflares outwardly in the rearward direction. As shown in FIG. 7, the basesurface 138 of the funnel region 132 can be angled upwardly (in arearward direction) relative to the bottom surface 108 of the base 102.The body 104 can further include wings 140 that each curve upwardly andoutwardly from the base surface 138 of the funnel region 132 and thatare each joined to a backstop portion 142 at a forward end thereof. Asshown in FIGS. 4 and 5, the wings 140 can extend outwardly past theperimeter 106 of the base 102 so as to provide for a wide entry mouth136 of the funnel region 132. The backstop portion 142 can rise upwardlyfrom an upper surface of the channel 134 and may include a surface thatis directed substantially vertically. The backstop portion 142 can spanthe channel 134, and at least a portion thereof can be positioneddirectly above the channel 134.

The funnel region 132 can fully encompass an entrance end of the channel134 and can encourage a tip of an access device 144, such as a needle(see FIG. 11B), to enter the channel 134. The funnel region 132 thus canserve as an enlarged target area that can assist in directing an accessdevice 144 to a desired portion of a vessel, as discussed further below.The funnel region 132 can comprise a material that can prevent ordiscourage a tip of an access device 144 from embedding therein orremoving a portion thereof as the tip moves toward the channel 134. Forexample, in various embodiments, the funnel region 132 can comprisetitanium, stainless steel, ceramic, rigid plastic, and/or similarmaterials.

At least a portion of the entry mouth 136 of the funnel region 132 caninclude a palpation projection 146, such as a palpation ridge. In theillustrated embodiment, the palpation projection 146 is substantiallyU-shaped and extends over the wings 140 and the backstop portion 142 ofthe funnel region 132, and the pinnacle region 122 of the body 104 islocated at a forward end of the palpation projection 146. The palpationprojection 146 can be rounded or radiused so as to be free from sharpedges that could lead to tissue erosion. As further discussed below, thepalpation projection 146 can be used to locate the vascular access port100 and/or confirm an orientation thereof when the port 100 ispositioned subcutaneously in a patient.

The entry mouth 136 of the funnel region 132 may be used to assist inachieving hemostasis after removal of an access device 144 from thevascular access port 100. To this end, the palpation projection 146 maysubstantially define a plane, in some embodiments. As shown in FIG. 6,the palpation projection 146 of the illustrated embodiment is nearly orsubstantially planar, as it is not perfectly planar due to a slightcurvature in the longitudinal direction. The palpation projection 146also exhibits a slight curvature in the transverse direction, as can beseen in FIG. 3. Moreover, in the illustrated embodiment, a rearward edgeof the entry mouth 136 smoothly transitions into the palpationprojection 146 at either end thereof and is only slightly below thesubstantially planar region defined by the palpation projection 146.Accordingly, as further discussed below, a seal can readily be formedabout a periphery of the entry mouth 136 of an implanted vascular accessport 100 by pressing tissue that surrounds the port 100 against at leastone of the palpation projection 146 and the entry mouth 136. In someinstances, the pressure may be applied in a single direction so as toachieve the seal. The smooth transitions can prevent trauma to tissuethat is pressed against the palpation projection 146 and/or the entrymouth 136 and, due to the substantially planar orientation thereof, canbe particularly well-suited for sealing when pressure is applied in adirection that is generally normal to the plane. Orientations other thansubstantially planar may also permit effective sealing of the entrymouth 136, as discussed further below.

In some embodiments, the palpation projection 146 can include one ormore bumps or other features which may cause the palpation projection146 to deviate from a substantially planar orientation. Such featuresmay provide additional information regarding the port 100, such as itsposition, orientation, etc. In other or further embodiments, thepalpation projections 146, which comprise bumps or other protrusions,may be located at positions that are spaced from a border of the entrymouth 136. For example, one or more palpation projections 146 may bepositioned on the body 104 at positions that are forward of the entrymouth 136.

With reference to FIG. 7, the channel 134 can extend through the base102, and a bottom end of the channel 134 can define an opening 150 inthe bottom surface 108 of the base 102. The opening 150 may be referredto as a distal opening 150 of the guidance passageway 130. The channel134 can be configured to constrain movement of one or more accessdevices 144 inserted individually therethrough along a predeterminedand/or repeatable path toward the opening 150. Accordingly, when thevascular access device 100 is fixed relative to a vessel, the channel134 and the opening 150 can cause the one or more access devices 144 tocannulate or pass through the same portion of the vessel. In certainembodiments, the channel 134 defines a substantially constant innerdiameter D along a length thereof, which can constrain the movement ofan access device 144 that has an outer diameter that is slightly smallerthan the diameter D. For example, in the illustrated embodiment, thechannel 134 is substantially cylindrical and can constrain movement of asubstantially cylindrical access device 144 (e.g., a fistula needle)that has an outer diameter slightly smaller than the diameter D (seeFIG. 11B) along a path that is coaxial with the channel 134. Thediameter D and/or the length of the channel 134 can be selected toachieve a desired degree of alignment for a given access device 144.

With continued reference to FIG. 7, the channel 134 can define a centralaxis AX, which can define an angle α relative to the bottom surface 108.For example, in the illustrated embodiment, the axis AX and alongitudinal line along the bottom surface 108 form the angle α. Theangle α can be acute relative to the longitudinal line, or moregenerally, can be nonparallel and/or non-perpendicular thereto. In FIG.7, the longitudinal line is represented in FIG. 7 by a line L thatdefines a longitudinal length of the base 10. When the vascular accessport 100 is connected to a vessel, the longitudinal line L can besubstantially parallel to a longitudinal axis of a lumen of the vessel(see FIG. 11A). Accordingly, in the illustrated embodiment, the channel134 can constrain movement of an access device 144 along a path that isboth nonparallel and non-orthogonal to the lumen of the vessel. Inparticular, the channel 134 can constrain movement of the access device144 along a path that is at or is approximately at the angle α relativeto the lumen of the vessel. In various embodiments, the angle α can havea value that is no greater than about 15, 20, 25, 30, 35, 45, or 60degrees; can have a value that is no less than about 10, 15, 20, 25, 30,35, 45, or 60 degrees; or can have a value that is within a range offrom about 30 degrees to about 60 degrees, from about 15 degrees toabout 45 degrees, or from about 20 degrees to about 35 degrees. Asfurther discussed below, some protocols for the creation and use ofbuttonhole cannulation sites can require introduction of a needle into avessel at a designated acute angle. Accordingly, certain embodiments ofthe vascular access port 100 can be configured for use with suchprotocols, and the angle α can be selected to correspond with the angledesignated by the protocol.

As previously discussed, the diameter D defined by the channel 134 canbe larger than a diameter of an access device 144 that is insertedthrough the channel 134. In some embodiments, the channel 134 is largerthan the access device 144 by a sufficient amount to allow the accessdevice 144 to pass through it easily or with little or no resistance.Reduction or elimination of insertion and removal forces between anaccess device 144 and the channel 134 can assist in maintaining a secureattachment between the vascular access port 100 and a vessel over thecourse of multiple insertion and removal events. Moreover, in theillustrated embodiment, the channel 134 is open, unobstructed, clear,free, or vacant. Stated otherwise, the channel 134 is devoid of closureapparatus, such as, for example, septums, valves, flaps, obturators,etc., which could be used to selectively open the channel 134 prior toor during insertion of an access device 144 therein, or which could beused to selectively close the channel 134 during or after removal of anaccess device 144 therefrom. The term “closure apparatus,” as usedherein, is directed to mechanical, electromechanical, or othersynthetic, foreign, or non-native devices or systems that may bemanufactured outside of a patient and introduced into a patient, butdoes not include natural or patient-generated materials that may closethe channel 134, such as, for example, clotted blood, tissue ingrowth,or vascular structures, such as a neointima or a pseudo vessel wall.

In certain embodiments, a configuration of the channel 134, or moregenerally, the guidance passageway 130, can remain unchanged uponinsertion of an access device 144 therein or removal of an access device144 therefrom, which may result, at least in part, from an absence ofclosure apparatus within the channel 134 or the guidance passageway 130.The channel 134 and/or the guidance passageway 130 may be substantiallyrigid or non-deformable. For example, a surface defining at least aportion of the guidance passageway 130 (e.g., a portion of the guidancepassageway 130 that is immediately adjacent to the opening 150) can benon-deformable. More generally, a configuration of the guidancepassageway 130 can remain unchanged upon insertion of an access device144 therein or removal of an access device 144 therefrom. In other orfurther embodiments, a configuration of the port 100 can remainunchanged upon insertion of an access device 144 therein or removal ofan access device 144 therefrom. Stated otherwise, in certainembodiments, no portion of one or more of the channel 134, the fullguidance passageway 130, and the vascular access port 100 in itsentirety may be deformed, rotated, translated, pivoted, expanded,contracted, reshaped, resized, or otherwise moved relative to remainingportions of one or more of the channel 134, the guidance passageway 130,and the vascular access port 100, respectively. Any resistive forces tothe insertion or removal of an access device 144 that might be providedby closure apparatus thus are absent during use of such embodiments ofthe vascular access port 100. Methods by which hemostasis may beachieved via embodiments of the vascular access port 100 that are devoidof closure apparatus are discussed below.

Manufacture of embodiments of the vascular access port 100 can befacilitated by their lack of closure apparatus. For example, in theillustrated embodiment, the vascular access port 100 comprises a unitarypiece and/or comprises a single material, and it is devoid of movingparts. Likewise, in the illustrated embodiment, the guidance passageway130 is defined by a single unitary piece and/or by a single material,and it is devoid of moving parts. Other or further embodiments maycomprise multiple parts that are fixedly attached to each other in anon-separable fashion. Embodiments of the vascular access port 100 canbe manufactured via any suitable method, such as machining, die casting,injection molding, etc., and may comprise any suitable biocompatiblematerial, such as, for example, titanium, stainless steel, rigidplastic, ceramic, etc. In some embodiments, the vascular access port 100comprises a resorbable material. For example, in various embodiments,the vascular access port 100 can comprise one or more of caprilactoneand glycolide (e.g., Panacryl, in proportions of about 90% and 10%,respectively); ε-caprolactone; cellulose; ethylene oxide with propyleneoxide (e.g., Pleuronic F-108); ethylene oxide with block polymer (e.g.,DynaGraft proloxamer); glycolide, dioxanone, and trimethylene carbonate(e.g., Biosyn, in proportions of about 60%, 14%, and 26%, respectively);glycolide and ε-caprolactone (e.g., Monocryl); hyaluronic acid ester(e.g., Hyaff); poly(butylene-terephthalate)-co-(polyethyleneglycol)(e.g., Poly-active, Osteo-active); polydioxanon (e.g., PDS);polyethyleenoxyde, polyglactin (e.g. Vicryl, Vicryl Rapide, Vicryl Plus,Polysorb); poly-glecapron (e.g., Monocryl); polyglycolic acid (e.g.,Dexon); polyglyconate (e.g., Maxon); polyglyceride (e.g., Trilucent);polylactic acid (e.g., PLLA); poly L-lactic acid (PLLA) and polyglycolicacid (PGA) (e.g., in proportions of about 82% and 18%, respectively);poly L-lactic acid (PLLA) and copolymer (e.g., Lactosorb);poly-L-lactide, poly-D-lactide, and poly-glycolide; polyvinylalcohol(e.g., Bioinblue); polysaccharide; and propylene oxide.

In other embodiments, the vascular access port 100 can be formed of acombination of materials. For example, as discussed further below, insome embodiments, the guidance passageway 130 can be formed of amaterial that remains rigid indefinitely, or for a relatively longperiod, such as titanium, stainless steel, or a first type of resorbablematerial, and other portions of the vascular access port 100 cancomprise a resorbable material, such as, for example, a second type ofresorbable material that is resorbed within the body of a patient muchquicker than is the first type of resorbable material.

With reference to FIG. 5, the base 102 can include one or moreingrowth-inducing features 151 of any suitable variety that canfacilitate integration or ingrowth of tissue in order to provide orenhance an attachment between a vessel and the vascular access port 100.The ingrowth-inducing features 151 can comprise the material ormaterials of which the base is formed, one or more structural features,and/or one or more coverings. For example, in some embodiments, the base102 may comprise a material such as hydroxyapatite, which is configuredto promote tissue ingrowth or tissue attachment thereto. In suchembodiments, the composition of the base 102 can constitute aningrowth-inducing feature 151 thereof. In the illustrated embodiment,the attachment passages 114 can promote tissue ingrowth in or throughthe base 102, and thus are identified in FIG. 5 as an ingrowth-inducingfeature 151 of the base 102. Other structural features can include, forexample, a dovetail groove.

In some embodiments, such as that illustrated in FIG. 5, aningrowth-inducing feature 151 can comprise an ingrowth-inducing covering152 that comprises a porous or roughened texture, which can be formed inany suitable manner. For example, in some embodiments, the texture isprovided by compaction and sintering of metallic beads or powders, suchas titanium beads, onto the base 102. In some embodiments, the beads mayhave a diameter of about 5 thousandths of an inch (i.e., approximately0.13 millimeters) or smaller. In various embodiments, theingrowth-inducing covering 152 can comprise a spherical bead porouscoating, a coating of asymmetrical powder, and/or a coating of irregularparticles such as those that are available from Orchid Bio-Coat ofSouthfield, Mich. In other or further embodiments, the ingrowth-inducingcovering 152 can be formed by machining, sandblasting, laser etching, orinjection molding of the base 102, or by attaching to the base 102 afabric, such as polyester, Dacron®, or e-PTFE. Stated otherwise, theingrowth-inducing covering 152 can be integrated into the base 102 orcan be applied to the base 102, and in either case, theingrowth-inducing covering 152 can be positioned at the bottom surface108 of the base 102.

In other embodiments, the ingrowth-inducing covering 152 can comprise aa porous material, such as a porous metal or plastic. For example, insome embodiments, the covering 152 comprises a plate that is formed ofporous titanium, such as, for example, Trabeculite™, which is availablefrom Tecomet of Wilmington, Mass. Other suitable porous materialsinclude Trabecular Metal™, which is available from Zimmer of Warsaw,Ind.

The ingrowth-inducing covering 152 can extend over the entire bottomsurface 108 of the base 102, as shown in the illustrated embodiment, orover a significant portion thereof. In some embodiments, it can bedesirable for the ingrowth-inducing covering 152 to cover a region thatis forward of and/or that encompasses at least a portion of the opening150 so as to provide a secure attachment between a vessel and the base102 in this region, which can assist in ensuring that access devices 144inserted through the opening 150 are consistently and repeatedlydirected to the same portion of the vessel. For example, an attachmentarea AR may be defined over which it is desirable to provide a secureattachment to a vessel. The attachment area AR may be encompassed by aseries of attachment passages 114 through which one or more attachmentdevices 116 may be advanced through the sidewall of a vessel into thelumen of a vessel to couple the vascular access device 100 to a vessel.The attachment area AR likewise may be covered by the ingrowth-inducingcovering 152 which can provide a further connection between the vascularaccess port 100 and an outer layer of the vessel (e.g., the adventitiaor media). The attachment area AR can surround the opening 150, asshown. In the illustrated embodiment, a rearward end of the attachmentarea AR is shown approximately at a middle region of the base 102. Inother or further embodiments, the attachment area AR can extend to anysuitable position up to a rearward end of the base 102.

In some embodiments, the base 102 can be provided with an adhesive (notshown) or other suitable coating in addition to or instead of theingrowth-inducing features 151 to provide a secure attachment betweenthe base 102 and a vessel. For example, in some embodiments, theadhesive can comprise cyanoacrylate or fibrin glue.

It can be desirable for the vascular access port 100 to be configuredfor sufficiently secure attachment to a vessel such that the port 100remains fixed relative to the vessel when it is influenced by forcesfrom a needle or other access device 144. For example, attachmentdevices 116 coupled to the attachment passages 114, tissue attached tothe ingrowth-inducing covering 152, and/or a bond provided by adhesivescan resist relative longitudinal movement between the vascular accessport 100 and the vessel when a tip of the access device 144 is urgedforwardly along the funnel region 132 or forwardly within the channel134. Similarly, such attachment features can resist relative rotationalmovement between the vascular access port 100 and the vessel when a tipof the access device 144 presses downwardly on either of the wings 140.

In some embodiments, it can be desirable to constrain theingrowth-inducing covering 152 to the bottom surface 108 of the base102, such as when it is desired to discourage, inhibit, or prevent thebody 104 from attaching to surrounding tissue when the vascular accessport 100 is implanted in a patient. For example, vessels can be somewhatmobile relative to surrounding tissue, and it may be more desirable forthe vascular access port 100 to remain fixed relative to a vessel ratherthan relative to the tissue that surrounds the vessel. Accordingly, insome embodiments, the body 104 is relatively smooth. In otherembodiments, at least a portion of the body 104 can comprise aningrowth-inducing covering 152.

As discussed further below, the ingrowth-inducing features 151 canprovide a seal about at least a portion of the opening 150. Withreference to FIG. 5A, the illustrated embodiment includes multipleattachment passages 114 that extend about the opening 150. Sutures orother suitable attachment devices 116 (see FIG. 8) can be advancedthrough the attachment passages 114 so as to connect the port 100 to avessel wall. The attachment devices 116 can be sufficiently tight tocause the bottom surface 108 to form seal with the vessel wall in aregion that extends about at least a portion of the opening 150. Theseal can prevent blood that has exited from a vessel to which the port100 is attached from moving between the bottom surface 108 of the port100 and the vessel wall. The seal thus formed via the attachment devices116 may be acute, and in further instances, the seal may be long-term.For example, in some embodiments the attachment devices 116 may beresorbable, such that the seal is primarily acute (e.g., may be presentonly during the first several access events through the port 100),whereas in other embodiments, the attachment devices 116 may be morepermanent, such that the acute seal formed thereby may persist for alonger period. A long-term seal that encompasses at least a portion ofthe opening 150 can also be formed by the ingrowth of tissue in orthrough the attachment passages 114.

Other ingrowth-inducing features 151 may be configured for the creationof a long-term seal that extends about at least a portion of the opening150. In the illustrated embodiment, the ingrowth-inducing covering 152extends about a full periphery of the opening 150. Over time, tissue canintegrate with or grow into the ingrowth-inducing covering 152. Suchingrowth can provide a seal that prevents blood from passing thereby.Accordingly, in some embodiments, a long-term seal that may take time toform (and thus may not necessarily be considered as an acute seal) canbe provided wherever the ingrowth-inducing covering 152 is located.Accordingly, in the illustrated embodiment, a seal can form about thefull periphery of the opening 150 and can fully encompass the opening150.

Additional illustrative arrangements of the ingrowth-inducing covering152 are shown in FIGS. 5B and 5C. In each illustrated embodiment, theattachment area AR includes attachment passages 114 that are arranged inthe same manner as those shown in FIG. 5A. The attachment passages 114thus can be used to form acute and/or long-term seals in manners such asdescribed above. In FIG. 5B, multiple swaths of an ingrowth-inducingcovering 152 extend outwardly from the opening 150. Theingrowth-inducing covering 152 thus partially or incompletelyencompasses or encircles the opening 150. When tissue integrates with orgrows into the ingrowth-inducing covering 152, it can create a sealabout a portion of the opening 150. In the illustrated embodiment, thelong-term seal formed by the ingrowth-inducing covering 152 can becomplementary to a long-term seal that can form when tissue growsthrough the attachment passages 114. Accordingly, in the illustratedembodiment, the separate varieties of ingrowth-inducing features151—namely, the attachment passages 114 and the ingrowth-inducingcovering 152—can fully encompass the opening 150 so as to promote thecreation of a seal about the entirety of the opening 150, even thougheach tissue-ingrowth feature 151 individually extends about only aportion of the opening 150.

FIG. 5C illustrates another arrangement of the ingrowth-inducingcovering 152 that only partially encompasses the opening 150 in a mannerthat is not complementary to the attachment passages 114. In such anembodiment, the ingrowth-inducing features 151, both collectively aswell as individually, only partially encompass or encircle the opening150.

It is to be appreciated that arrangements of the ingrowth-inducingfeatures 151 other than those illustrated in FIGS. 5A-5C are alsopossible. Moreover, while only the attachment passages 114 and theingrowth-inducing covering 152 are illustrated in these drawings, it isto be understood that any other suitable arrangement or combination ofingrowth-inducing features is possible.

With reference more generally to FIGS. 1-7, in some embodiments, atleast a portion of the vascular access port 100 can include a covering(not shown), such as a coating and/or an embedded portion, thatcomprises one or more materials or agents that provide antiseptic,antimicrobial, antibiotic, antiviral, antifungal, anti-infection, orother desirable properties to the vascular access port 100, such as theability to inhibit, decrease, or eliminate the growth of microorganismsat or near a surface of the port. For example, in various embodiments,the vascular access port 100 can comprise one or more of silver,platinum, gold, zinc, iodine, phosphorus, bismuth, alexidine,5-flurouracil, chlorhexidine, sulfadiazine, benzalkonium chloride,heparin, complexed heparin, benzalkonoium chloride, 2,3dimercaptopropanol, ciprofloxacin, cosmocil, cyclodextrin,dicloxacillin, EDTA, EGTA, myeloperoxidase, eosinophil peroxidase,fusidic acid, hexyl bromide, triclosan, polymyxin B, isopropanol,minocycline rifampin, minocycline EDTA, octenidine, orthophenyl phenol,triclocarban, triclosan, cephazolin, clindamycin, dicloxacillin, fusidicacid, oxacillin, rifampin, antibodies, peptides, polypeptides, freefatty acids, and oxidative enzymes. In some embodiments, the coatingand/or the embedded material may be separate or independent from (e.g.,non-coextensive with) the ingrowth-inducing covering 152. For example,in some embodiments, the ingrowth-inducing covering 152 is constrainedto the base 102 of the vascular access port 100, whereas anantimicrobial covering is constrained to the body 104 of the vascularaccess port 100.

In the illustrated embodiment, a forward face 156 of the body 104 risessmoothly from the base 102 and is angled rearwardly. As shown in FIG. 7,in some embodiments, the forward face 156 may generally follow a contourof the channel 134 and may be substantially parallel thereto. Forexample, the forward face 156 can be convexly rounded in a mannersimilar to the channel 134. The body 104 can smoothly transition fromthe forward face 156 into depressions 158 at either side thereof, whichcan provide for a relatively smaller surface area of the body to whichtissue might attach. The depressions 158 can reduce the material costsassociated with manufacture of the vascular access port 100.

Various parameters of the vascular access port 100 can be adjusted orselected to achieve a desired performance. For example, with referenceto FIG. 3, a maximum width WF of the funnel region 132 can be greaterthan a maximum width WB of the base 102. Such an arrangement may bedesirable where the vascular access port 100 is configured to be coupledwith a relatively small vessel, or where a relatively large target areaotherwise is desired. In various embodiments, the width WF is no lessthan about 1.0, 1.25, 1.50, 1.75, or 2.0 times the value of the widthWB.

In some embodiments, the width WB of the base 102 can be approximatelythe same as or smaller than a width of a vessel to which the vascularaccess port 100 is configured to be attached. In various embodiments,the width WB of the base 102 can be no less than about 6, 7, 8, 9, 10,11 or 12 millimeters, or can be no more than about 6, 7, 8, 9, 10, 11,or 12 millimeters.

In some embodiments, a height H of the vascular access port 100 can beadjusted or selected depending on the depth at which the port 100 is tobe implanted within the patient. For example, some embodiments of thevascular access port 100 may be well-suited for use with a shallowvessel, such as a vein associated with an arteriovenous fistula in aforearm, whereas other embodiments may be well-suited for use withdeeper vessels, such as the basilic vein in the upper arm. The depth atwhich the port 100 is located beneath a surface of the skin of thepatient also can vary from patient to patient due to differences inanatomy. Sites at which various embodiments of the vascular access port100 can be implanted include the cephalic, basilic, median antecubital,saphenous, femoral, jugular, subclavian, or other suitable veins; thefemoral, radial, ulnar, brachial, femoral, or other suitable arteries;fistulas; the stomach; other organs; or, more generally, any suitablestructure where a walled membrane encircles or encapsulates a region.

In some embodiments, it can be desirable for an implanted vascularaccess port 100 to be beneath an outer surface of the skin of a patientby a sufficient amount to prevent tissue erosion, yet not so deep thatpalpation of the vascular access port 100 is difficult or providesinsufficient information regarding the position or orientation of theport. In various embodiments, a minimum distance between an outersurface of the skin of a patient and an implanted port is no more thanabout 3, 4, 5, or 6 millimeters, is no less than about 3, 4, 5, or 6millimeters, or is about 3, 4, 5, or 6 millimeters.

The height H can be defined as a minimum distance between the pinnacleregion 122 and the bottom surface 108 of the base 102, and the height Hcan be selected, adjusted, or otherwise configured so as to achieve adesired depth of the vascular access port 100 beneath the surface of theskin of a patient. In various embodiments, the height H can be nogreater than about 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15millimeters, or can be no less than about 2, 3, 4, 5, 6, 7, 8, 9, 10,11, 12, 13, 14, or 15 millimeters. In other or further embodiments, theheight H can be no more than about 0.1, 0.2, 0.3, 0.4, 0.5, 0.75, 1.0,1.5, 2.0, 2.5, 3.0, or 3.5 times the width WB of the base 102, or can beno less than about 0.1, 0.2, 0.3, 0.4, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5,3.0, or 3.5 times the width WB of the base 102. In other or furtherembodiments, the angle α, as defined above, can vary with the height H.For example, in some embodiments, the angle α increases with increasingheight H.

With reference to FIGS. 2-5 and 6, portions of the body 104 and the base102 define an outermost periphery 160 of the port 100. The outermostperiphery 160 represents a maximum extent of the port 100 in each of thelateral and longitudinal directions. As shown in FIGS. 4 and 5, in theillustrated embodiment, the outermost periphery 160 includes a forwardcontinuous region 161 and a rearward continuous region 162 that meet attwo discontinuous positions 163 (see also FIG. 1), where the ends of theforward and rearward continuous regions 161, 162 are verticallyseparated from each another. The forward continuous region 161 isdefined by a forward end of the perimeter 106 of the base 102. A portionof the rearward continuous region 162 is defined by a rearward end ofthe perimeter 106 of the base 102. At two continuous transition points164, the rearward continuous region 162 extends upwardly and forwardlyfrom the base 102 along an outer periphery of the body 104 and towardthe discontinuous positions 163.

With reference again to FIGS. 2, 3, and 6, the outermost periphery 160can be extended vertically (i.e., upwardly and/or downwardly) so as todefine a peripheral extent 166 of the port. As shown in FIGS. 4 and 5,when the port 100 is viewed in a top plan view or a bottom plan view,the three-dimensional nature of the peripheral extent 166 collapses totwo dimensions such that the peripheral extent 166 corresponds with anoutline of the port 100.

With reference to FIG. 5, the port 100 can define a footprint 168, whichis the portion of the port 100 that is configured to come into directcontact with a vessel when the port 100 is connected to the vessel. Inthe illustrated embodiment, the footprint 168 is coextensive with thebottom surface 108 of the base 102. Moreover, in the illustratedembodiment, the footprint 168 is smaller than the peripheral extent 166of the port 100. Stated otherwise, an outermost perimeter 169 defined bythe footprint 168 is interior to the peripheral extent 166 of the port100. In the illustrated embodiment, the outermost perimeter 169 of thefootprint 168 is also shaped differently from the peripheral extent 166of the port 100.

It will be appreciated that various features of the embodiments of thevascular access port 100 discussed above can be altered or modified. Forexample, in some embodiments, the base 102 and the body 104 compriseseparate pieces that are joined to each other. By way of illustration,the base 102 may comprise a relatively compliant material that canreadily change shape so as to conform to a surface of a vessel, while atleast a portion of the body 104 (e.g., the funnel region 132) cancomprise a relatively rigid material. In other or further embodiments,the cavity 110 defined by the base 102 can be sized to receive anyportion of a circumference of a vessel therein. Different sizes andconfigurations of the guidance passageway 130 are also possible, asfurther discussed below.

The vascular access port 100 can be implanted in a patient and used inany suitable methods. As mentioned above, it can be desirable to securethe vascular access port 100 to a vessel in such a manner that theopening 150 defined by the guidance passageway 130 is fixed relative tothe vessel, which can allow the guidance passageway 130 and/or theopening 150 to repeatedly direct an access device to the same portion ofthe vessel.

FIG. 8 depicts an example of one such arrangement. The vascular accessport 100 is fixedly and directly secured to a vessel 200, whichcomprises three layers: the tunica adventitia (or adventitia) layer 202,the tunica media (or media) layer 204, and the tunica intima (or intima)layer 206. The term “direct,” when used herein with reference tosecuring or attaching a vascular access port 100 to the vessel 200,means that some portion of the vascular access port 100 is in abuttingcontact with the vessel 200 and is fixedly attached thereto. In theillustrated embodiment, an attachment device 116 comprises a runningsuture that extends through each attachment passage 114 of the vascularaccess port 100. One or more loops of the suture can extend through allthree layers 202, 204, 206 of the vessel 200.

In certain embodiments, it can be desirable to ensure that one or moreattachment devices 116 extend through more layers of the vessel 200 thanjust the adventitia layer 202 (or a portion thereof), or statedotherwise, through the media and/or the intima layers 204, 206. Forexample, it has been found that attachment of certain ports solely tothe adventitia layer 202 (i.e., without attachment to other tissues) canresult in mobility of the ports relative to the media and intima layers204, 206. The ports may shift longitudinally and/or laterally relativeto the inner layers 204, 206 of the vessel 200 from such activities aspalpation of the ports during cannulation procedures or variousday-to-day occurrences. Such mobility of a vascular access port canpotentially result in the creation of multiple access sites in thevessel 200 over the course of repeated cannulations, which can weakenthe vessel wall over time and potentially result in an aneurysm, vesselstenosis, hematoma, and/or bleeding. In some instances, it can bedesirable for one or more attachment devices 116 that are used to attachthe port 100 to the vessel 200 to extend through at least the intimalayer 206. In further instances, it can be desirable for one or moreattachment devices 116 to extend through at least the intima and medialayers 206, 204.

Without being limited by theory, it is believed that immobilizing,stabilizing, or fixing the port 100 relative to the media layer 204permits fibrous tissue to grow between the media layer and into anysuitable portion of the port 100, such as an ingrowth-inducing portion.For example, the one or more attachment devices 116 can be used tosecure the port 100 relative to the media layer 204. Thereafter, fibroustissue can further secure the port 100 relative to the media layer 204.The attachment devices 116 thus may primarily be used to facilitatetissue ingrowth, although in some embodiments, long-term presence of theattachment devices 116 may assist in maintaining the port 100 fixedrelative to the vessel 100 when extreme loads are applied thereto, suchas by an inadvertent bumping or twisting of the implanted port 100.

FIGS. 9A-9E depict various stages of an illustrative method forimplanting a vascular access port 100 in a patient 210 such that thevascular access port 100 provides direct access to a vessel within thepatient 210. The term “patient” is used broadly herein and includes anyanimal subject who can or does undergo some process or procedure,whether provided by another or self-administered, and the term is notlimited to an individual within a healthcare facility. The vascularaccess port 100 may be used with any suitable vessel, such as an artery212, a vein 214 (both shown in FIG. 9A), or an artificial graft (seeFIG. 14B). As previously discussed, the vessel may be at any of avariety of positions within the patient 210, such as the neck, the upperarm, the forearm, or the leg, and it may be located at a relatively deepor shallow position relative to the skin 216 of the patient. Numeroususes of an implanted port 100 are possible, including, for example,hemodialysis, chemotherapy, antibiotic therapy, total parenteralnutrition, pain management, aquapheresis, plasmapheresis, hydration, orlong-term therapies of any suitable variety. In the illustrated method,a vascular access port 100 is shown being implanted in a forearm of thepatient 210—specifically, the vascular access port 100 is shown beingconnected to a vein 214 that is associated with an arteriovenous fistula218 for use in hemodialysis. It is noted that the vein 214 is athree-layered vessel such as the vessel 200 depicted in FIG. 8, and thusmay be referred to hereafter as a vessel 200 to illustrate the moregeneral applicability of the procedures discussed.

With reference to FIG. 9A, an incision 220 can be made in the skin 216of the patient 210. In the illustrated embodiment, the incision 220 canbe from about 4 centimeters to about 5 centimeters in length. Theincision 220 can extend substantially parallel to the vessel 200, butcan be offset relative thereto (i.e., is not directly over the vessel200). In the illustrated embodiment, the incision 220 is offset from aposition directly over the vessel 200 by a distance of from about 2centimeters to about 3 centimeters. As discussed further with respect toFIG. 9E, such an orientation of the incision 220 can facilitate accessto the vascular access port 100 after the implantation procedure iscomplete. In other methods, the incision 220 can be directly over thevessel 200 and/or at an angle or entirely transverse relative thereto.The incision 220 can be made by a practitioner 224 using any suitabletechniques and instruments.

With reference to FIG. 9B, the vessel 200 can be exposed by removing,partially removing, or separating skin, fat, and fascial layers from theadventitia layer 202 of the vessel 200 at the site of the incision 220.Exposure of the vessel 200 can be maintained in any suitable manner,such as by the use of tissue spreaders 230.

With reference to FIG. 9C, an initial attachment of the vascular accessport 100 to the vessel 200 can be achieved at the front end or the backend of the vascular access port 100. In some procedures, an attachmentdevice 116 can be inserted through all three layers 202, 204, 206 (seeFIG. 8) of the vessel 200 and through an attachment passage 114 at eachof the front and back ends of the vascular access port 100 along alateral center of the port 100 prior to use of any of the remainingattachment passages 114. Initial attachment of the front end and/or theback end of the vascular access port 100 can assist in ensuring that adesired orientation of the vascular access port 100 is achieved andmaintained during the course of the implantation procedure.

As previously mentioned, any suitable attachment device (or devices) 116may be used in securing the vascular access port 100 to the vessel 200.The attachment devices 116 can include, for example, one or moresutures, pinch rings, hooks, or wires. Once an attachment device 116 isin a desired position, it can be securely tied, crimped, twisted, orotherwise fastened.

In the illustrated embodiment, the attachment device 116 comprises arunning suture, which can be looped through multiple attachment passages114. In the illustrated embodiment, a single running suture 116 is usedto secure the vascular access port 100 to the vessel 200. In otherembodiments, the suture 116 may extend through fewer passages 114 andone or more additional sutures 116 may be used. For example, aspreviously discussed, in some embodiments, a separate suture 116 issecured at each end of the vascular access port 100 prior to providingsutures in any of the remaining attachment passages 114.

Various options are available for securing one or more sutures 116 inplace. For example, in some procedures, a suture needle 232 can beinserted through the wall of the vessel 200 at a position near anattachment passage 114, and can then pass through the attachment passage114 after having passed through the vessel wall. A suture 116 associatedwith the suture needle 232 can then be tied using a surgical knot andthe excess suture trimmed. In other procedures, a suture 116 can bepositioned at a desired location within the wall of the vessel 200 suchthat at least one leg thereof protrudes from the adventitia layer 202.The protruding leg of the suture 116 can be received through a desiredattachment passage 114 of the vascular access port 100 as the port 100is brought into contact with the vessel 200. The suture 116 can then betied and trimmed. Either approach may be used to secure sutures 116through any desired number of attachment passages 114 of the vascularaccess port 100. Any other suitable suturing or attachment technique maybe used. In some embodiments, only a portion of the available attachmentpassages 114 are used.

With reference to FIG. 9D, additional sutures 116 can be used to securethe vascular access port 100 to the vessel 200 via any or all of theremaining attachment passages 114, as desired. In some embodiments, theattachment passages 114 are filled, such as with silicone, so as toprevent ingrowth of tissue. In other embodiments, the attachmentpassages 114 are left open, which can permit ingrowth of tissue thereinor therethrough.

With reference FIG. 9E, the site of the incision 220 can be closed inany suitable manner, such as, for example, via one or more sutures 234.As previously mentioned, the incision 220 can be offset from a positionthat is directly above the vascular access port 100. In sucharrangements, an access device 144 can be inserted through the skin 216to the vascular access port 100 via a surface insertion site 236 withlittle or no interaction with the site of the incision 220, or statedotherwise, without contacting any or much scar tissue at or beneath thesurface of the skin 216, and this can facilitate the insertion of theaccess device 144. Likewise, palpation of the port 100 can proceedwithout interaction with scar tissue, which could otherwise complicateor obscure such palpation.

In certain embodiments, it can be desirable to wait for a period of daysor weeks after implantation of the vascular access port 100 beforeaccessing the vessel 200 thereby. The waiting period can providesufficient time for tissue ingrowth at the appropriate areas of thevascular access port 100, which can provide a more secure connectionbetween the vascular access port 100 and the vessel 200.

FIGS. 10A-10G depict various stages of another illustrative method forimplanting a vascular access port 100 in the patient 210 such that thevascular access port 100 provides direct access to the vessel 200 withinthe patient 210. Although the methods shown in FIGS. 9A-9E and 10A-10Gare depicted relative to the same site within the patient 210, it is tobe understood that the methods also may be used at other sites.

With reference to FIG. 10A, an incision 220 can be made in the skin 216of the patient 210, which in some embodiments can be from about 4centimeters to about 5 centimeters in length. The incision 220 canextend substantially parallel to vessel 200 and can be offset relativethereto. In some embodiments, the offset can be by a distance of fromabout 2 centimeters to about 3 centimeters.

With reference to FIG. 10B, the vessel 200 can be exposed by removing,partially removing, or separating skin, fat, and fascial layers from theadventitia layer 202 of the vessel 200 at the site of the incision 220.In some cases, a hemostat 240 can assist in this process. Exposure ofthe vessel 200 can be maintained in any suitable manner, such as by theuse of tissue spreaders 230.

With reference to FIG. 10C, a portion of the adventitia 202 can beisolated or separated from other portions of the vessel 200 in anysuitable manner, such as via one or more forceps 242. Each set offorceps 242 can be used to capture or gather up a portion of theadventitia 202 and/or fascia layers or fat that may not have beenremoved or spread apart by the tissue spreaders 230.

With reference to FIG. 10C, while the portion of adventitia 202 is beingheld in its separated state, a small incision 244 can be made therein inany suitable manner, such as via a scalpel or via scissors 246.

With reference to FIG. 10D, a hemostat 240 can be inserted through theincision 244 so as to slide between the isolated adventitia 202 and theremaining layers of the vessel 200. In some instances, it can bedifficult to separate all of the adventitia 202 from the media layer 204of the vessel 200. This, in the illustrated embodiment, the media layer204 is shown, but is obscured by a thin layer of adventitia 202. Thehemostat 240 can be used to bluntly dilate a pocket 248 within theadventitia 202 layer. Although not depicted, in some cases, the forceps242 may be used to maintain control of the adventitia 202 duringformation of the pocket 248.

In certain embodiments, the pocket 248 can be sufficiently large toreceive the vascular access port 100 therein, while in others, thepocket 248 can be slightly smaller than the vascular access port 100. Insome embodiments, the pocket 248 can have a length of no more than about2.0, 2.5, 3.0, or 3.5 centimeters, and can have a width of no more thanabout 70, 80, or 90 percent of a width of the outer diameter of themedia layer 204.

With reference to FIG. 10E, the vascular access port 100 can be insertedthrough the incision 244 into the pocket 248. In some cases, the forceps242 or other clamping devices are used to maintain control of theadventitia 202 during insertion of the vascular access port 100. Thevascular access port 100 can be introduced into the pocket 248 eitherrearward end first, as shown, or forward end first, and the port 100 canbe pushed to the end of the pocket 248 opposite the incision 244.

With reference to FIG. 10F, the adventitia 202 can cover all orsubstantially all of the implanted vascular access port 100 when it iswithin the pocket 248. Sutures 116 can be advanced through theadventitia 202, through the attachment passages 114, and through theremaining portion of the adventitia layer 202, as well as through theentirety of the media and intima layers 204, 206 to attach the vascularaccess port 100 to the vessel 200. Suture knots thus may be tied outsideof the adventitia 202. In other embodiments, the sutures 116 do not passthrough the separated portion of the adventitia 202 and may be tiedprior to being covered by the adventitia 202.

FIG. 10G depicts the site of the incision 220 in a closed configuration.The incision 220 can be closed in any suitable manner, such as in any ofthe manners described above with respect to FIG. 9E.

With reference again to FIGS. 10C-10F, in other methods, at least aportion of the adventitia 202 can be removed rather than forming thepocket 248 therein. The vascular access port 100 may be placed atop athin layer of the adventitia 202 at a site from which the at least aportion of adventitia 202 has been removed, and sutures 116 may bedirectly inserted through the attachment passages 114 and through thethinned adventitia layer 202, the media layer 204, and the intima layer206. The vascular access port 100 may, at least initially, be lessstable relative to the vessel 200 when it is implanted in this manner,rather than when it is inserted into the pocket 248.

FIGS. 11A-11E depict various procedures that may be performed relativeto an implanted vascular access port 100. As will be discussed, thevascular access port 100 can facilitate the creation of a buttonhole.The vascular access port 100 likewise can facilitate use of thebuttonhole once it is formed. These and/or other advantages of thevascular access port 100 will be apparent from the disclosure thatfollows.

Additionally, as previously mentioned, tissue may grow into or attach tovarious areas of the vascular access port 100. For example, vesseltissue may grow into the ingrowth-inducing covering 152. In someembodiments, skin tissue may grow into at least a portion of theguidance passageway 130, although such ingrowth is not shown in FIGS.11A-11E.

FIG. 11A depicts an embodiment of the vascular access port 100 that hasbeen implanted in the patient 210 in any suitable manner, such as viathe method depicted in FIGS. 9A-9E. The opening 150 of the guidancepassageway 130 is at or adjacent to the vessel 200. Specifically, in theillustrated embodiment, the opening 150 is at the adventitia layer 202of the vessel 200.

In the stage that is shown, a clinician 260 palpates the skin 216 tolocate and determine the orientation of the vascular access port 100.The term “clinician” is used broadly herein and includes any individualwho conducts a process or procedure relative to an implanted access port100, whether that individual is the individual in whom the access port100 is implanted (e.g., a patient) or someone else, and the term is notlimited to an individual within a healthcare facility. In theillustrated embodiment, the clinician 260 uses fingers to contact theskin 216 located above the pinnacle region 122 of the palpationprojection 146. In other instances, the clinician 260 can palpate anyother suitable portion of the body 104 to determine the location (e.g.,depth) and orientation of the port 100. For example, the clinician 260may use one or more fingers and/or a thumb to contact the skin 216 thatis over or beside other portions of the palpation projection 146, or tosqueeze the skin 216 that is at either side of the wings 140. In stillother or further embodiments, a clinician may visually determine alocation and orientation of the port 100. Prior or subsequent to thestage shown in FIG. 11A, the clinician 260 can clean a surface of theskin with any suitable antiseptic so as to reduce the risk ofintroducing pathogens into the bloodstream of the patient.

FIG. 11B illustrates an embodiment of an access device 144 directlyaccessing a lumen 262 of the vessel 200 via the vascular access port 100for a first time. The access device 144 is advanced through the skinsuch that an outer surface of the device 144 contacts the skin. Theaccess device 144 is further advanced through the port 100, and theninto the vessel 200. Although the fingers of the clinician 260 are notshown in FIG. 11B, the clinician 260 may continue to palpate thevascular access port 100 while inserting the access device 144 into theskin and the vascular access port 100. This can aid in achieving adesired alignment of the access device 144 with the guidance channel130. The clinician 260 also may make minor adjustments to an orientationof the vascular access port 100 by applying pressure thereto.

The access device 144 can comprise any suitable device configured forfluid communication between a position outside of the skin 216 and thevessel lumen 262 when the device has been introduced into the lumen 262via the vascular access port 100. For example, in various embodiments,the access device 144 can comprise a needle or a catheter. In manyembodiments, the access device 144 can be relatively rigid so as to beable to readily pass through the skin 216. Accordingly, in someembodiments, the catheter may be an over-the-needle catheter.

Standard needles that are presently used in hemodialysis or otherprocedures may be used with embodiments of the vascular access port 100,which may facilitate use of such ports. For example, standard protocolsfor making and using buttonholes in vessels via known freehand methodsmay be readily adapted to “device-assisted” buttonhole techniques thatemploy the vascular access ports 100, and this can take place withoutalteration to the instruments called for by the existing protocols.

As the procedural stage depicted in FIG. 11B represents an initialaccess of the vessel lumen 262, the access device 144 is shown as havinga sharp tip or cutting edge 145, which can allow the access device 144to more readily be inserted through the unbroken skin so as to form aninsertion tract 264, and also so as to create an insertion site 266 ofthe vessel 200. As further discussed below, however, other embodimentsof an access device 144 that have blunt ends may be used after at leastan initial access event with a sharp access device has occurred. Forexample, as discussed hereafter, in some embodiments, sharp accessdevices 144 can be used for a number of access events (e.g., 6, 7, 8, 9,or 10 access events) until an insertion tract may have been formedthrough the skin of a patient, and blunt access devices 144 can be usedthereafter. In other embodiments, a sharp access device 144 is used foran initial insertion event, and blunt access devices 144 can be usedthereafter.

In certain embodiments, the access device 144 can comprise a needlesized from 14 gauge to 20 gauge. As previously mentioned, the diameterand length of the channel 134 can be configured to constrain movement ofthe access device 144 along a path that is coaxial with the channel 134so as to direct the access device 144 to a specific region of the vessel200. This may be achieved by a relatively close fit between the channel134 of the vascular access port 100, which can provide for a predictableorientation at which the access device 144 will exit the channel 134through the opening 150. In some instances, it may be desirable for thechannel 134 to be sized such that at least a small amount of spaceexists between an inner wall thereof and an access device 144 when theaccess device 144 is inserted therein. This can prevent or reducebinding of the access device 144 within the channel 134, which may bemore likely to occur if tissue has grown into at least a portion of thechannel 134. In some embodiments, a balancing or optimization may beachieved with respect to the spacing between the channel 134 and anaccess device 144 such that a sufficiently tight fit is achieved toallow the vascular access device 144 to be directed repeatedly tosubstantially the same area of the vessel 200 and to achieve hemostasiswhen the vascular access device 144 is inserted into the vessel 200,while inhibiting, reducing the occurrence of, or preventing binding ofthe vascular access device 144 within the channel 134. In variousembodiments, an inner diameter of the channel 134 is larger than anouter diameter of an access device 144 with which it is configured to beused by an amount within a range of from about 0.25 gauge to about 3.0gauge, from about 0.5 gauge to about 2.0 gauge, from about 0.75 gauge toabout 1.5 gauge, or from about 0.75 gauge to about 1.25 gauge; by anamount that is no less than about 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75,2.0, 2.5, or 3.0 gauge; or by an amount that is no greater than about0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, or 3.0 gauge. In someembodiments, the channel 134 is about 1 gauge larger than access devices144 with which it is configured to be used. For example, in theillustrated embodiment, the channel 134 may be sized at approximately 14gauge and the access device 144 can comprise a 15 gauge fistula needle.

Other configurations for the channel 134 and the access device 144 arealso possible. For example, one or more of the channel 134 and theaccess device 144 may have geometries other than cylindrical. In certainof such embodiments, the geometries of the channel 134 and of the accessdevice 144 may be complementary to each other, whereas in otherembodiments, a cross-sectional shape of the channel 134 may be differentfrom a cross-sectional shape of the access device 144.

In some instances, it can be desirable to insert the access device 144into the vessel in a bevel-up orientation, as shown in FIG. 11B. Inparticular, the illustrated access device 144 includes a bevel 147 at adistal end thereof. When the access device 144 is inserted in thebevel-up orientation, the bevel 147 extends upwardly from a distal-mostpoint of the access device 144. Many protocols for accessing a vesselwith a needle or other access device indicate a preference for insertingthe access device in such a bevel-up orientation. As can be appreciatedfrom FIG. 11B, when the access device 144 is in a bevel-down orientationit would be rotated by approximately 180 degrees relative to theillustrated orientation, such that the bevel 147 would extend primarilyrearwardly in the longitudinal direction rather than primarily upwardlyin the vertical direction, as shown.

As can be seen in FIG. 11B, when the access device 144 is advancedthrough the guidance passageway 130 in a proximal-to-distal direction,the cutting edge 145 of the access device 144 proceeds through theopening 150 and into contact with a wall of the vessel 200. Upon furtheradvancement of the access device 144, the cutting edge 145 cuts throughthe vessel wall and progresses into the lumen 262 of the vessel 200. Insome embodiments, the cut or incision thus created by the cutting edge145 can be semi-circular, which can result in a convexly shaped flapportion of the vessel wall.

With continued reference to FIG. 11B, the cutting edge 145 of the accessdevice 144 has been advanced into the lumen 262 of the vessel 200sufficiently far such that it is outside of the peripheral extent 166 ofthe port 100. However, it can be seen that when the cutting edge 145 ofthe access device 144 is at a position that is vertically even with anapex of the footprint 168, it is also approximately at a surface of thevessel wall. At this position, the cutting edge 145 is at an interior ofthe peripheral extent 166 of the port 100.

In the illustrated embodiment, the guidance passageway 130 defines aclosed loop about the access device 144 when it has been advancedthrough the passageway. Stated otherwise, the guidance passageway 130 isenclosed so as to fully encircle the access device 144 once it has beenadvanced through the opening 150. Stated in yet another manner, theguidance passageway 130 fully encircles the opening 150. Such anarrangement can, for example, assist in directing the access device 144toward the opening 150 when the distal tip of the access device 144 isbrought into contact with any portion of the guidance passageway 130 asit is advanced toward the vessel 200.

As previously mentioned, some protocols for the creation and use ofbuttonhole cannulation sites can require introduction of a needle into avessel at a designated acute angle. In some embodiments, the angle αdefined by the channel 134 (see FIG. 7) can be matched to this specifiedangle, and the channel 134 can constrain the access device 144 to enterthe vessel 200 at the angle α, such that the vascular access port 100can be configured for use with such protocols.

Tenting of the vessel wall can be inhibited by the formation of a sealabout the opening 150, as tissue can tightly grab or integrate into theport 100 in this region as discussed above. The vessel wall thus can beheld relatively taut within the area that is internal to an outer edgeof the opening 150. The taut vessel wall can be relatively resilient asthe access device 144 is passed therethrough. This resilience, which mayresult from the seal or tissue integration about the opening 150, can bereferred to as a trampoline effect. Accordingly, where sufficient timehas passed for formation of the seal, an initial access event via theaccess device 144 may cause relatively little deformation of the vesselwall as the access device 144 passes therethrough. Deformation is alsoreduced by the use of a sharp-tipped device for the initial access. Ascan be appreciated from the discussion that follows, in someembodiments, a reduction in tenting can also be advantageous wheresubsequent access events are performed with blunt-tipped devices.

FIG. 11C illustrates a stage of the procedure after removal of theaccess device 144. The insertion site 266 is shown in a closed state, inwhich it is allowed to heal. Prior to closure and/or healing of theinsertion site 266, however, blood 268 can be permitted to exit thereby,and may fill at least a portion of the guidance passageway 130 and theinsertion tract 264. The practitioner 260 can apply pressure above thevascular access port 100 to close the insertion tract 264 until bleedingsubsides at the surface of the skin 216. For example, the practitioner260 can apply pressure while simultaneously applying a pad 269 (e.g.,gauze) to the upper end of the insertion tract 264. As previouslymentioned, the entry mouth 136 of the guidance passageway 130 can beconfigured to assist in achieving hemostasis. For example, the entrymouth 136 may be relatively planar, and application of pressure abovethe entry mouth 136 can cause tissue surrounding the guidance passageway130 to effectively seal the guidance passageway 130 about the entrymouth 136. In some embodiments, a two-finger technique may be used toclose the insertion tract 264 while applying pressure to the tissuepositioned above the guidance passageway 130. In some embodiments,pressure may be applied for a period of no more than about 5, 6, 7, 8,9, or 10 minutes in order to achieve hemostasis.

It is also noted that removal of the access device 144 from the vessel200 can be achieved without removing a portion of the vessel wall fromthe patient. For example, when a sharp-tipped needle is used, the needlecan cut the wall of the vessel 200 as described above, and removal ofthe needle can allow the cut edges in the wall to come back into closeproximity or contact with each other.

A relatively tight attachment between the vascular access port 100 andthe vessel 200 so as to achieve a seal (whether acute or long-term) asdescribed above within the attachment area AR (see FIG. 5) likewise canassist in reaching hemostasis. For example, tightly attached sutures orother attachment devices and/or tissue ingrowth about the opening 150can inhibit or prevent blood 268 from seeping outwardly between the base102 of the vascular access port 100 and the vessel 200. The seal can atleast partially encompass the opening 150.

In some instances, the procedures discussed with respect to FIGS.11A-11C can be repeated multiple times. For example, with referenceagain to FIG. 11B, a second access device 144 having a sharp tip 145 canbe inserted through the insertion tract 264 toward the vascular accessport 100 for a second insertion event. However, during the time betweenthe first and second access events and/or as a result of palpation ofthe vascular access port 100 during the second access event, thevascular access port 100 and the vessel 200 to which it is attached mayhave shifted relative to the insertion tract 264 such that the channel134 is no longer aligned with the insertion tract 264. As the accessdevice 144 is advanced through the insertion tract 264, the tip of theaccess device 144 can contact the funnel region 132. The funnel region132 then can direct the tip of the access device 144 into the channel134 as the access device 144 is further advanced through the insertiontract 264. In some cases, this redirection of the tip of the accessdevice 144 relative to the vascular access port 100 may urge theinsertion tract 264 and the channel 134 into alignment with each other.Once the tip of the access device 144 enters the channel 134, thechannel 134 directs the tip of the access device 144 to the insertionsite 266 of the vessel 200. The vascular access port 100 thus can directthe access device 144 to the same insertion site 266 via which thevessel lumen 262 was accessed in the first access event. As furtherdiscussed below with respect to FIGS. 23A-23E, in some instances, asimilar result can be achieved without direct contact between the accessdevice 144 and the funnel region 132. For example, the funnel region 132can be coated with tissue ingrowth, and the funnel region 132 canconstrain movement of the access device 144 so as to direct it towardthe single insertion site 266.

FIG. 11D depicts the insertion tract 264 and the insertion site 266after multiple access events. As shown, the insertion tract 264 maybecome more well-defined over time. Without being limited by theory, thewell-defined insertion tract 264 may result, for example, from theformation of scar tissue or connective tissue. Similarly, the insertionsite 266 may become more well-defined over time such that it may becomeeasier to insert an access device 144 therethrough. Such an insertionsite 266 through a vessel wall can be referred to as a buttonhole accesssite, or more commonly, as a buttonhole. Accordingly, the insertion site266 may also be referred to herein as a buttonhole 266. In someembodiments, the well-defined insertion tract 264 and/or the buttonhole266 may be established after 6, 7, 8, 9, or 10 access events. In someembodiments, the buttonhole 266 may be formed more quickly. For example,the buttonhole insertion site 266 may be present upon insertion of asharp access device 144 into the vessel 200. So long as the insertionsite 266 is not allowed to completely heal, a blunt access device 144may readily be inserted through the insertion site 266. For example, itmay be desirable to permit the insertion site 266 to heal for no morethan one, two, three, or four days before a subsequent access event.

In other embodiments, the insertion tract 264 and/or the buttonhole 266can be formed by inserting an over-the-needle catheter (not shown)through the vascular access port 100. The needle portion can be removedand the catheter portion can be left in place until the insertion tract264 is well-defined. The catheter then can be removed.

As previously discussed, the vascular access port 100 and the vessel 200may shift relative to the insertion tract 264 between access events.However, in certain embodiments, the funnel region 132 of the guidancepassageway 130 is sufficiently large that a distal end of the insertiontract 264 opens into, or extends through at least a portion of, thefunnel region 132 despite any such shifting. Accordingly, the vascularaccess port 100 may act as a mobile extension of the insertion tract264, which is configured to ensure that access devices 144 areconsistently directed to the buttonhole 266, despite any relativemovement between the insertion tract 264 and the vessel 200. In someinstances, however, relatively little shifting may occur between theinsertion tract 264 and the vascular access port 100, and an accessdevice 144 may be inserted through the insertion tract 264 and directlyinto the channel 134 with little or no contact with either the funnelregion 132 or the channel 134. As previously mentioned, the guidancepassageway 130 may be covered by tissue, which can further ensure thatcertain access events may take place without direct contact between theaccess device 144 and the guidance passageway 130.

FIG. 11D also illustrates that a scab 270 may form over the insertiontract 264 between access events. The scab 270 may be removed prior to anaccess event. In other embodiments, a synthetic covering may be providedover or in place of the scab 270.

FIG. 11E illustrates the use of an access device 144 having a bluntdistal tip 149 after formation of the insertion tract 264 and thebuttonhole 266. The blunt tip 149 of the access device 144 can guide thedevice 144 through the insertion tract 264 and through the buttonhole266, and may do so in a less traumatic or more comfortable manner forthe patient 210. Use of a blunt-tipped access device 144 also can reducethe risk of striking through an opposing side of the vessel 200. In theillustrated embodiment, the access device 144 includes a bevel 147, andthe access device 144 is inserted in a bevel-up orientation.

As previously discussed, in some embodiments, a seal forms about theopening 150 prior to access events in which a blunt-tipped access device144 is used. Such a seal can hold the vessel wall in a relatively tautand/or resilient fashion and can inhibit tenting of the vessel wall.This effect, also referred to as a trampoline effect, can facilitateinsertion of the blunt-tipped device through the buttonhole 266. Forexample, without being limited by theory, the blunt-tipped access device144 may force open the buttonhole 266 so that the device can be insertedinto the vessel lumen 262, rather than cut open the buttonhole 266. Thebuttonhole 266 thus may be more resistant to a forced opening, asopposed to a cutting event. Accordingly, the seal can steady the vesselwall and allow the wall to resist the forced opening without a largedegree of deformation up to the point where the buttonhole 266 yieldsand the access device 144 is advanced therethrough. This can aid in thecontinued use and maintenance of a single buttonhole access site 266.

As previously mentioned, in some embodiments, an over-the-needlecatheter can be used with an implanted vascular access port 100. Incertain procedures, a needle/catheter assembly can be inserted throughthe insertion tract 264 into the vessel 200 (e.g., the jugular vein) andthen the catheter can be advanced through the vessel to the desiredposition (e.g., the superior vena cava for certain central venous systemapplications). An infusion or other desired procedure can then beconducted. The catheter can be removed from the patient after completionof the procedure.

FIG. 12 depicts an embodiment of the vascular access port 100 that hasbeen implanted in the patient 210 via a method such as that depicted inFIGS. 10A-10G. A portion of the adventitia layer 202 of the vessel 200thus extends over the vascular access port 100. Accordingly, when anaccess device 144 is inserted into the vessel 200 via the access port100, it passes through the adventitia layer 202 before entering thevascular access port 100. Otherwise, procedures for creating and usingbuttonholes can be similar to those described above with respect toFIGS. 11A-11E.

FIG. 13 depicts an illustrative example of an embodiment of a buttonholeaccess site 266 in a vessel 200 that was formed by repeated insertion ofaccess devices 144 through an embodiment of a vascular access port 100.FIG. 13 is a photograph of a filleted portion of the vessel 200, and isshown from a bottom plan view thereof (i.e., a view directed toward theintima layer 206). A contour of the vascular access port 100 is visiblein the photograph, as are portions of a running suture 116 that extendthrough the intima layer 206.

In this particular example, the vascular access port 100 was implantedin a sheep for a period of 9 weeks. After a waiting period to permit fortissue ingrowth, a sharp needle was inserted through the vascular accessport 100 to access the vessel 200. Six (6) additional access events wereconducted thereafter using a sharp needle, followed by twelve (12)access events using a blunt needle. Accordingly, a total of nineteen(19) cannulations were performed. The access events were conducted at afrequency of three per week.

FIG. 14A depicts an embodiment of a hemodialysis system 300 thatincludes two vascular access ports 100A, 100B, which can resemble any ofthe vascular access ports described herein. Both of the ports 100A, 100Bare shown attached to a vessel 200 that is associated with anarteriovenous fistula 218. One port 100A is directed upstream such thata forward end thereof points in a direction opposite to the flow ofblood through the vessel 200 (e.g., points in a retrograde direction),and the other port 100B is directed downstream such that a forward endthereof points in the direction of the blood flow through the vessel 200(e.g., points in an antegrade direction). A fistula needle may beintroduced into each of the ports 100A, 100B and hemodialysis performed.The first port 100A can be an uptake port through which blood is removedfrom the vessel 200 and delivered to a hemodialysis machine, and thesecond port 100B can be a return port through which filtered blood isreturned to the vessel 200 from the hemodialysis machine.

In other embodiments, the hemodialysis system 300 can comprise only asingle vascular access port 100A or 100B. Hemodialysis may be conductedthereby via any suitable method, such as a single-needle hemodialysistechnique.

In still other embodiments, the hemodialysis system 300 includes morethan two vascular access ports 100A, 100B. A clinician thus can rotateamong the ports 100A, 100B, thereby leaving one or more of the portsunused during any given hemodialysis session.

FIG. 14B depicts another embodiment of a hemodialysis system 350. Theillustrated embodiment includes two vascular access ports 100A, 100B,but more or fewer ports are possible. Both of the ports 100A, 100B areshown attached to an artificial graft vessel 352 that serves as a shuntbetween an artery 212 and a vein 214. The graft vessel 352 can compriseany suitable material, such as e-PTFE. The ports 100A, 100B can beattached to the graft vessel 352 prior to its implantation, or may beattached to the graft vessel 352 after it has been implanted. Thehemodialysis system 350 can function similarly to the system 300described above, with the port 100A serving as an uptake port and theport 100B serving as a return port.

FIG. 15 illustrates an embodiment of a system 400 configured for theexternal treatment of blood. The system 400 is similar to the system 300described above. The system 400 includes two vascular access ports 100A,100B, which can resemble any of the ports described herein. Both of theports 100A, 100B are shown attached to a vessel 200 that is associatedwith an arteriovenous fistula 218. One port 100A is directed upstreamsuch that a forward end thereof points in a direction opposite to theflow of blood through the vessel 200, and the other port 100B isdirected downstream such that a forward end thereof points in thedirection of the blood flow through the vessel 200, although otherarrangements are possible. A separate access device 144 (e.g., fistulaneedle or over-the-needle catheter) may be introduced into each of theports 100A, 100B via any of the methods described above and connected toa blood treatment system 402 (e.g., hemodialysis machine) via anysuitable passageways 404 (e.g., tubing).

Blood treatment then can then be performed. The first port 100A can bean uptake port through which blood is removed from the vessel 200 anddelivered to the blood treatment system 402, and the second port 100Bcan be a return port through which treated blood is returned to thevessel 200 from the blood treatment system 402. Accordingly, in use,blood is removed from the patient via an access device 144 that iswithin the first port 100A and delivered to the blood treatment system402. The removed blood is treated in any suitable manner via the bloodtreatment system 402. Treated blood is returned to the patient via anaccess device 144 that is within the second port 100B.

In other embodiments, the system 400 can comprise only a single vascularaccess port 100A or 100B. Blood treatment may be conducted thereby viaany suitable method (e.g., a single-needle hemodialysis technique). Instill other embodiments, the system 400 includes more than two vascularaccess ports 100A, 100B. A clinician thus can rotate among the ports100A, 100B, thereby leaving one or more of the ports unused during anygiven blood treatment session.

FIGS. 16A-16G illustrate another embodiment of a vascular access port500, which can resemble the vascular access port 100 described above incertain respects. Accordingly, like features are designated with likereference numerals, with the leading digits incremented to “5.” Relevantdisclosure set forth above regarding similarly identified features thusmay not be repeated hereafter. Moreover, specific features of thevascular access port 500 may not be shown or identified by a referencenumeral in the drawings or specifically discussed in the writtendescription that follows. However, such features may clearly be thesame, or substantially the same, as features depicted in otherembodiments and/or described with respect to such embodiments.Accordingly, the relevant descriptions of such features apply equally tothe features of the vascular access port 500. Any suitable combinationof the features and variations of the same described with respect to thevascular access port 100 can be employed with the vascular access port500, and vice versa. This pattern of disclosure applies equally tofurther embodiments depicted in subsequent figures and describedhereafter.

The vascular access port 500 can include a base 502 and a body 504. Thebase defines a perimeter 506 that is substantially rectangular, exceptfor a rounded front end. An outermost periphery 560 of the port 500 canbe continuous about an entirety thereof. In the illustrated embodiment,the outermost periphery 560 is defined entirely by the perimeter 506 ofthe base 502. Stated otherwise, the body 504 does not extend outwardlyto a greater lateral or longitudinal extent than does the base 502.However, at two regions 570 of the port 500, the body 504 and the base502 extend outwardly to the same lateral position so as to be even witheach other thereat. Accordingly, it could be said that the body 504cooperates with the base 502 to define a portion of the outermostperiphery 560 of the port 500. A vertical extension or projection of theoutermost periphery 560 defines a peripheral extent 566 of the port 500.

As can be seen in FIGS. 16A and 16B, a width WF of the funnel region 532of the vascular access port 500 can be less than a width WB of the base502. Wings 540 of the body 504 may not extend past a perimeter 506 of abase 502 of the port 500. In the illustrated embodiment, the outer edgesof the wings 540 are substantially parallel to each other and extendupwardly from the base 502. The narrower arrangement of the wings 540thus can result in a smaller entry to or proximal opening of the funnelregion 532, as compared with the port 100.

The port 500 can include a palpation projection 546 that fullyencompasses the funnel region 532. As shown, for example, in FIG. 16F,the palpation projection 546 can be substantially planar. A planedefined by the palpation projection 546 can define an acute anglerelative to a bottom end of the base 502 such that a forward end of thepalpation projection 546 is at a greater vertical height than is arearward end thereof. Additionally, a forward face 556 of the port 500can define an acute angle relative to a bottom surface 508 of the base502. In the illustrated embodiment, the port 500 includes a channel 534that defines a central axis AX that is at an acute angle relative to thebottom surface 508 of the base 502. The acute angles defined by theforward face 556 and the central axis AX both open rearwardly, or statedotherwise, are both directed forwardly. However, the acute angle definedby the forward face 556 is smaller than the acute angle defined by thecentral axis AX.

FIG. 17A illustrates another embodiment of a vascular access port 600,which can resemble the vascular access ports described above in certainrespects. The port 600 can include a base 602 that comprises a graftextension 605, which can aid in securely attaching the port 600 to avessel. In the illustrated embodiment, the graft extension 605 can befixedly attached to a remainder of the base 602 via one or more sutures116. Any other suitable method for attaching the graft extension 605 tothe base 602 may be used. The graft extension 605 can comprise anysuitable material, which may be flexible so as to permit naturalfluctuations in the vessel diameter. The material may also promotetissue ingrowth. In some embodiments, the graft extension 605 comprisese-PTFE. In the illustrated embodiment, a first side of the graftextension 605 (not shown) is coupled with the port 600 and a second side609 is unattached thereto.

As shown in FIG. 17B, the graft extension 605 can be positioned about aat least a portion of a vessel 200 and one or more attachment devices116 can be inserted through the port 600, through the various layers ofthe vessel 200, and through the graft extension 605 and then secured(e.g., tied off). Additional attachment devices 116 may also be usedrelative to the port 600 in manners such as discussed above.

In some embodiments, the vascular access port 600 can be used to repaira fistula. For example, in some embodiments, the base 602 (e.g., thegraft extension 605) can be positioned about an aneurism in a vesselwall.

In certain embodiments, the graft extension 605 may be replaced with ahousing element (not shown) that is configured to encompass at least aportion of the vessel 200 in a manner such as that depicted in FIG. 17B.The housing element can comprise any suitable biocompatible material,and may be sufficiently rigid to prevent an access device 144 fromstriking through a side of a vessel that is opposite the port 600.

In various embodiments, at least a portion of the graft extension 605 orthe housing element can include a covering (not shown), such as acoating and/or an embedded portion, that comprises one or more materialsor agents that provide antiseptic, antimicrobial, antibiotic, antiviral,antifungal, anti-infection, or other desirable properties to thevascular access port 600, such as the ability to inhibit, decrease, oreliminate the growth of microorganisms at or near a surface of the port.For example, any suitable covering material listed above may be used.

FIG. 18 illustrates an embodiment of a vascular access system 700. Thesystem 700 includes an artificial graft vessel 701 and a vascular accessport 703 attached thereto. The vascular access port 703 can resemble anyof the access ports described above. However, in some embodiments, abottom surface 708 of the port 703 may be devoid of an ingrowth-inducingcovering. The bottom surface 708 may be provided with an adhesive tocreate a tight bond between the port 703 and the graft vessel 701. Insome embodiments, a fluid-tight seal is provided between the port 703and the graft vessel 701, which can prevent blood or other fluids fromseeping between the port 703 and the graft vessel 701 during or after anaccess event. One or more attachment devices 116 may be used to attachthe port 703 to the graft vessel 701. The graft vessel 701 can compriseany suitable material, such as, for example, e-PTFE.

FIG. 19 illustrates another embodiment of a vascular access port 800.The vascular access port 800 includes a flexible patch 805 connected toa base 802 thereof. The patch 805 extends outwardly beyond a peripheryof the body 802. The patch 805 can comprise any suitable biocompatiblematerial, and can promote tissue ingrowth therein. For example, invarious embodiments, the patch 805 comprises one or more of Dacron,e-PTFE, or polyurethane foam. The patch 805 can be conformable to anexterior surface of a vessel to which it is attached, and it may beattached to the vessel by one or more of sutures, clips, or othersuitable devices. The patch 805 can be configured to encompass at leasta portion of the vessel to which it is attached.

In the illustrated embodiment, the base 802 is bowed so as to conform toa wall of a vessel. As with other ports described herein, in otherembodiments, the base 802 may be substantially planar or shaped inanother configuration. For example, in some embodiments, at least aportion of the base 802 may be formed of a flexible or conformablematerial. In certain of such embodiments, the base 802 can be configuredto conform to an outer surface of a vessel wall. For example, in someembodiments, the base 802 can comprise the patch 805, which maynaturally have a substantially planar configuration, and the patch 805can be bowed when it is joined to a vessel wall.

FIG. 20 illustrates another embodiment of a vascular access port 900.The vascular access port 900 includes a supportive component 924 and adirective component 926 that have different properties, such as, forexample, different resistances to puncturing, duration times onceimplanted in a patient, and/or material costs. In various embodiments,each of the supportive and directive components 924, 926 can form atleast a portion of one or more of a base 902 and a body 904 of thevascular access port 900. For example, in the illustrated embodiment,each of the supportive and directive components 924, 926 help form thebody 904, whereas, of the two, only the supportive component 924contributes to the base 902.

In some embodiments, the supportive and directive components 924, 926are configured to maintain a predetermined form within a patient fordifferent periods of time once the vascular access port 900 has beenimplanted. For example, in some embodiments, the supportive component924 is configured to be resorbed within a patient more quickly than isthe directive component 926. For example, in various embodiments, thesupportive component 924 is resorbed at a rate that is no more thatabout 1.5, 2, 3, 4, 5, 6, 7, 8, 9, or 10 times the rate at which thedirective component 926 is resorbed, or the supportive component 924 isresorbed at a rate that is no less than about 1.5, 2, 3, 4, 5, 6, 7, 8,9, or 10 times the rate at which the directive component 926 isresorbed. In some embodiments, the directive component 926 is configuredto resist resorption, and may remain within a patient indefinitelywithout being resorbed. In some embodiments, the supportive component isconfigure to be fully resorbed within a period of no more than about 1,2, 3, 4, 5, or 6 months or no less than about 1, 2, 3, 4, 5, or 6months.

In various embodiments, one or both of the supportive and directivecomponents 924, 926 can comprise a resorbable material, such as, forexample, any suitable resorbable material described above. In other orfurther embodiments, the directive component 926 can comprise anon-resorbable material, such as stainless steel, titanium, or the like.

A substantial portion of a guidance passageway 930 can be defined by thedirective component 926. For example, in the illustrated embodiment, anentire funnel region 932 and an entrance end of a channel 934 are formedby the directive component 926. In contrast, only an exit end of thechannel 934 is formed by the supportive component 924. As it is moreresistant to being resorbed, the directive component 926 can resistcoring and scraping by a needle or other insertion device 144 for alonger duration, and thus can assist in creating an insertion tractthrough the skin of a patient to a buttonhole and/or can assist in thecreation of the buttonhole itself.

The supportive component 924 can encompass a forward end of thedirective component 926, as shown. The supportive and directivecomponents 924, 926 can be joined to each other in any suitable manner.For example, the components 924, 926 can be adhered or welded to eachother. In some embodiments, the supportive component 924 is overmoldedonto the directive component 926.

Tissue that replaces the supportive component 924 can in turn supportthe directive component 926 in a similar manner such that the directivecomponent 926 can generally maintain the same orientation within apatient once the supportive component 924 has been resorbed. In someembodiments, an outer surface of the directive component 926 (e.g., asurface opposite the guidance passageway 930) can include any suitableingrowth-inducing features, such as the ingrowth-inducing covering 152described above. Accordingly, as the supportive component 924 isreplaced with tissue, the tissue can be firmly attached to the directivecomponent. Additionally, as with the ports discussed above, at least abottom surface 908 of the vascular access port 900 can include aningrowth-inducing covering 952.

In some embodiments, different materials may be used for the supportiveand directive components 924, 926 as a cost-saving measure. For example,a less durable, less expensive material may be used for the supportivecomponent 924 with little or no difference in the performance of certainembodiments of vascular access ports described above. In someembodiments, the directive component 926 may comprise a coating or layerof a material having intrinsic strength and/or that is capable ofimparting strength to the supportive component 924.

FIGS. 21A-21G illustrate another embodiment of a vascular access port1000, which can resemble the vascular access ports described above incertain respects. The vascular access port 1000 can comprise a base 1002that is devoid of attachment passages. Accordingly, the port 1000 may beattached to a vessel by some method other than suturing or the like,such as via a biocompatible adhesive. However, in other embodiments, thevascular access port 1000 includes attachment passages such as theattachment passages 114 discussed above.

The port 1000 can include a guidance passageway 1030 that varies fromthe guidance passageway 130 depicted in FIGS. 1-7. In particular, theguidance passageway 1030 comprises a funnel region 1032 that extendsfrom one or more of a palpation projection 1046 and an entry mouth 1036to an opening 1050 in the base 1002. The funnel region 1032 decreases insize in a vertically downward direction such that a width of the funnelregion becomes smaller toward the opening 1050. The funnel region 1032also decreases in size in a longitudinally forward direction such that awidth of the funnel becomes smaller in a rearward-to-forward direction.

As can be seen in FIG. 21G, a backstop portion 1042 of the funnel region1032 is angled rearwardly and extends over (e.g., is positioned above)the opening 1050. A base surface 1038 of the funnel region is alsoangled rearwardly. The funnel region 1032 thus can be said to be angledrearwardly in its entirety.

The guidance passageway 1030 does not include a channel portion, such asthe channel 134 described above, that defines a substantially constantcross-sectional area along a given length. In some instances, theabsence of a channel can prevent or inhibit binding of an access device144 as it is inserted through the passageway 1030 and/or removedtherefrom. As can be seen from a comparison of FIG. 5 and FIG. 21E, theopening 1050 can define the same ovoid shape as the opening 150 that isat the end of the cylindrical channel 134. Accordingly, the opening 150can be configured to closely conform to an outer surface of acylindrical access device 144 that is inserted therethrough at apreferential angle, or at an angle within a preferential range. In someinstances, such as where the size of the access device 144 is closelymatched to the size of the opening 150, binding may occur when theaccess device 144 is inserted or removed from the opening 150 at anangle that is not within a preferential range. Such close matching mayoccur where an outer diameter of the access device 144 is smaller than amaximum lateral width of the opening 150 by any of the gauge valuesdescribed above with respect to the channel 134.

The funnel region 1032 can define multiple angles relative to the base1002. With reference to FIG. 21G, which represents a cross-section ofthe port 1000 along a central vertical-longitudinal plane thereof, afront surface of the funnel region 1032 can define a maximum angle βrelative to the base 1002, and a rear surface of the funnel region 1032can define a minimum angle γ relative to the base 1002. A central axisAX of the guidance passageway 1030 can pass through a center of theopening 1050 along the central vertical medial plane at an anglerelative to the base that has a value defined by (β+γ)/2. In someembodiments, a preferential range of angles over which an access device144 may be inserted through the opening 1050 with little or no bindingcan include the angle (β+γ)/2 defined by the central axis AX. In otherembodiments, the angle (β+γ)/2 may be outside of the preferential rangesuch that the central axis AX does not necessarily correspond with(e.g., is not aligned or coaxial with) a longitudinal, central axis ofan access device 144 when the access device 144 has been insertedthrough the opening 1050. For the embodiment illustrated in FIGS.21A-21G, the angle (β+γ)/2 defined by the central axis AX can be acute.For example, a value of the angle (β+γ)/2 can be the same as any of thevalues discussed above with respect to the angle α defined by thecentral axis AX of the port 100.

FIGS. 22A-22G illustrate another embodiment of a vascular access port1100, which can resemble the vascular access ports described above incertain respects. The vascular access port 1100 can comprise a base 1102similar to the base 102 described above. The vascular access port 1100can further comprise a body 1104 that extends vertically and, in someregions, laterally away from the base 1102.

Similar to the outermost periphery 160 of the port 100, an outermostperiphery 1160 of the port 1100 is discontinuous, as it transitions fromthe body 1104 to the base 1102 at various discontinuous positions 1163,1164 (see FIGS. 22A and 22E). In the illustrated embodiment, a largemajority of the outermost periphery 1160 is defined by a perimeter ofthe body 1104, as the body 1104 includes large wings 1140 that extendlaterally outward beyond the base 1102 and are also elongated in thelongitudinal direction. Only a small portion of the outermost periphery1160 is defined by the front and rear ends of the base 1102. A verticalprojection or extension of the outermost periphery 1160 defines aperipheral extent 1166 of the port 1100 (see FIGS. 22B, 22C, and 22F).

The port 1100 includes a guidance passageway 1130 that comprises afunnel region 1132 that extends from one or more of a palpationprojection 1146 and an entry mouth 1136 to an opening 1150 in the base1102. The funnel region 1132 decreases in size in a vertically downwarddirection such that a width of the funnel region becomes smaller towardthe opening 1150. The funnel region 1132 also decreases in size in alongitudinally forward direction such that a width of the funnel becomessmaller in a rearward-to-forward direction.

With reference to FIGS. 22D and 22G, a backstop portion 1142 of thefunnel region 1132 is angled forwardly such that at least a portionthereof is forward of the opening 1150. The backstop portion 1142 mayalso be said to angle outwardly from the opening 1150 in an upwarddirection. A base surface 1138 of the funnel region is also angledrearwardly or outwardly from the opening 1150 in the upward direction,and may extend to a vertical height that is less than a vertical heightto which the backstop portion 1142 extends. Side regions 1139 of thefunnel region 1132 likewise are angled outwardly from the opening 1150in the upward direction. The funnel region 1132, in its entirety, thuscan be said to be angled outwardly from the opening in the upwarddirection. Stated otherwise, the funnel region 1132 can constrictinwardly from all sides in a downward direction. In other embodiments,the backstop portion 1142 may extend in a true vertical direction, so asnot to be angled outwardly or inwardly, or it may extend vertically andrearwardly, so as to be angled rearwardly (as discussed below withrespect to FIG. 28G). As can be seen in FIG. 22D, the backstop portion1142 can be rounded and, in the illustrated embodiment, is substantiallyconically shaped.

With reference to FIGS. 22F and 22G, the palpation projection 1146 candefine a substantially planar surface that is angled relative to thelongitudinal direction. In the illustrated embodiment, the substantiallyplanar surface is gently bowed so as to be convexly rounded at a centralregion of the port 1100. The palpation projection 1146 increases inheight in the forward direction so as to reach a maximum height at aforward end of the port 1100. As can be seen in FIG. 22G, at least aportion of the palpation projection 1146 can be at a position that isforward of the opening 1150.

With reference to FIGS. 22D and 22E, the opening 1150 can be larger thanthe opening 1050 discussed above. For example, where the ports 1000,1100 are configured for use with an access device 144 of a given outerdiameter, the opening 1150 can be longer than the opening 1050, orstated otherwise, can be more elongated in the longitudinal direction.Due to the greater length of the opening 1150, an access device 144 canbe inserted through the opening 1150 at a larger variety of angles.Moreover, the opening 1150 can inhibit, reduce, or eliminate binding ofthe access device 144 after it has been inserted, particularly where thedevice is inserted through the opening 1150 such that a central axisthereof is aligned with a central vertical-longitudinal plane 1120 (seeFIG. 22B). As discussed further below, such binding can be inhibited,reduced, or eliminated when the access device 144 is at an anglerelative to a bottom surface 1108 of the base 1102 that is within a widerange of angles. A larger opening 1150 also can allow for greater ormore consistent tissue ingrowth through the opening 1150 and may preventdirect contact between an access device 144 and the edges of the opening1150.

In the illustrated embodiment, the opening 1150 includes a semicircularforward end 1180 and a rectangular rearward end 1182, which has roundedcorners. Stated otherwise, a portion of the rearward end 1182 of theopening 1150 is defined by a non-curved or straight portion. Oppositesides 1184 extend between the forward and rearward ends 1180, 1182. Inthe illustrated embodiment, the sides 1184 define substantially straightlines that are substantially parallel to each other. Accordingly, acontour or periphery of the opening 1150 can include one or morenon-curved, straight, or linear portions. The sides 1184 can provide aspacing between the forward and rearward ends 1180, 1182 that can reducebinding of an access device 144.

As shown in FIG. 22E, a maximum length LO of the opening 1150 can begreater than a maximum width WO of the opening. In various embodiments,the length LO can be greater than the width WO by no less than a factorof 1.5, 2.0, 2.5, 3.0, or 3.5, by a factor that is within a range offrom about 1.5, 2.0, 2.5, or 3.0 to about 3.5, or by a factor that iswithin a range of from about 1.5, 2.0, or 2.5 to about 3.0. In other orfurther embodiments, the width WO can be greater than an outer diameterof an access device 144 that is used with port 1100 by an amount withina range of from about 0.1 gauge to about 3.5 gauge, from about 0.25gauge to about 3.0 gauge, from about 0.5 gauge to about 2.0 gauge, fromabout 0.75 gauge to about 1.5 gauge, or from about 0.75 gauge to about1.25 gauge; by an amount that is no less than about 0.1, 0.25, 0.5,0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, or 3.0 gauge; or by an amount thatis no greater than about 0.1, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75,2.0, 2.5, or 3.0 gauge. In some embodiments, the width WO is about 1.0or about 2.0 gauge larger than an outer diameter of the access devices144 with which it is configured to be used. In other or furtherembodiments, the length LO of the opening 1150 is greater than an outerdiameter of the access device 144 by no less than a factor of 1.5, 2.0,2.5, 3.0, 3.5, or 4.0.

In some embodiments, a relatively close fit between the width WO of theopening 1150 and an outer diameter of the access devices 144 with whichthe port 1100 is configured to be used can help to prevent or inhibit anaccess device 144 from penetrating through a sidewall of a vessel 200after having been introduced into the lumen of the vessel through theopening 1150. In particular, such a relatively close fit can cause theaccess device 144 to enter a lumen of the vessel 200 in a direction thatis aligned, substantially aligned, or defines a relatively small anglewith the central vertical-longitudinal plane 1120 of the port 1100, andthe central vertical-longitudinal plane 1120 of the implanted port 1100can be aligned, or substantially aligned, with a longitudinal axis ofthe vessel 200. Such an arrangement can constrict movement of the accessdevice 144 such that a tip thereof remains spaced from the lateral sidesof the vessel 200.

The funnel region 1132 can define multiple angles relative to the base1102. With reference to FIG. 22G, which represents a cross-section ofthe port 1100 along the central vertical-longitudinal plane 1120, afront surface of the funnel region 1132 (i.e., the backstop portion1142) can define a maximum angle β relative to the bottom surface 1108of the base 1102 within the plane 1120, and a rear surface of the funnelregion 1132 can define a minimum angle γ relative to the bottom surface1108 of the base 1102 within the plane 1120. A central axis AX of theguidance passageway 1130 can pass through a center of the opening 1150along the central vertical medial plane at an angle relative to thebottom surface 1108 of the base 1102 that has a value defined by(β+γ)/2. In the illustrated embodiment, the angle (β+γ)/2 is acute. Aswith the port 1000 discussed above, the value of the angle (β+γ)/2 canbe the same as any of those discussed above with respect to the angle αdefined by the central axis AX of the port 100.

In some embodiments, a range of angles over which an access device 144may be inserted through the opening 1150 with little or no binding caninclude the angle (β+γ)/2 defined by the central axis AX. Moreover,other angles that are greater or smaller in value than the angle (β+γ)/2also may result in little or no binding such that the central axis AXdoes not necessarily correspond with (e.g., is not aligned or coaxialwith) a central axis of an access device 144 when the access device 144has been inserted through the opening 1150. For example, a substantiallycylindrical access device having an outer diameter that is only slightlysmaller than the width W_(O) of the opening 1150, such that it can beinserted through the opening 1150 along the central verticallongitudinal plane 1120 and contact opposing lateral sides of theopening 1150, can be inserted through or removed from the opening 1150without binding over a range of angles. As can be appreciated from theforegoing, in such an arrangement, binding can occur due to contactbetween the access device 144 and one or more of the forward andrearward ends 1180, 1182 of the opening 1150. Stated otherwise, theforward and rearward ends 1180, 1182 can interact with the access device144 to define a minimum angle and a maximum angle at which no binding ofthe access device 144 occurs. A difference between the maximum andminimum angles at which no binding occurs can be no less than about 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, or 90degrees, can be no more than about 5, 10, 15, 20, 25, 30, 35, 40, 45,50, 55, 60, 65, 70, 75, 80, 85, or 90 degrees, or can be within a rangeof from about 5, 10, 15, 20, 25, 30, 40, 45, 50, 55, 60, 65, 70, or 75degrees to about 90 degrees, from about 5, 10, 15, 20, 25, 30, 40, or 45degrees to about 60 degrees, or from about 5, 10, 15, 20, 25, 30 degreesto about 45 degrees.

With reference to FIG. 22D, in some embodiments, the opening 1150 issufficiently elongated to permit a single access device 144 to createmultiple discreet insertion sites 266 in a vessel to which the port 1100is attached, depending on the angle at which the access device 144 isinserted. For example, in the illustrated embodiment, a large number ofseparate insertion sites 266 (see FIGS. 11C-11E) can be created in eachof three distinct insertion regions 1185 that are shown as phantomcircles in FIG. 22D. The contours of the three distinct insertionregions 1185 represent an outer surface of an access device 144 that isinserted vertically through the opening 1150. Fewer insertion regions1185 that have larger outer contours are possible with increasinglyshallower angles of the access device 144 relative to the base 1102. Forexample, the contours of the insertion regions 1185 can become moreovoid than the circular contours illustrated in FIG. 22D when the accessdevice 144 is inserted at shallower angles. At a minimum insertion angleat which no binding occurs (i.e., at angles less than the minimuminsertion angle, the insertion device 144 will bind), the opening 1150can accommodate only a single insertion region 1185, which can define anovoid contour such as, for example, the periphery defined by the opening150 (see FIG. 5). The forward and rearward ends of such a singleinsertion region 1185 can be substantially even with the forward andrearward ends 1180, 1182 of the opening 1150. Accordingly, at theminimum insertion angle, only a single insertion site 266 may be formedin a vessel via the port 1100. In various embodiments, where asubstantially cylindrical access device is used that has an outerdiameter that is only slightly smaller than the width W_(O) of theopening 1150, such that it can be inserted through the opening 1150along the central vertical longitudinal plane 1120 and contact opposinglateral sides of the opening 1150, the minimum insertion angle can be noless than about 10, 13, 15, 17, 20, 25, 30, 35, or 45 degrees. In someillustrative embodiments, a minimum insertion angle (i.e., the angle atwhich a single insertion region is present) can be about 17 degrees, andwhen an access device 144 is inserted at an angle of 20, 25, 30, or 35degrees, about 1.1, 1.4, 1.6, and 1.9 insertion regions are possible,respectively.

As shown in FIG. 22E, the non-curved sides 1184 of the opening 1150define an elongated region 1181 of the opening 1150 that can allow notonly for the range of insertion positions in the longitudinal direction,as just discussed, but also provide a substantially constant constraintrelative to the access device 144 in the lateral direction at any of thepossible insertion positions. Stated otherwise, the opening 1150 can besufficiently elongated to permit a single access device 144 to createmultiple discreet insertion sites 266 in a vessel to which the port 1100is attached (e.g., at a given insertion angle, more than one insertionregion 1185 may be present). The non-curved sides 1184 of the opening1150 that define the elongated region 1181 can permit the access device144 to experience the same amount of constraint or guidance in thelateral direction at any of the longitudinal insertion positions justdiscussed.

Standard vascular access procedures often call for inserting an accessdevice 144 into a lumen of a vessel at an angle within a range of fromany of about 20, 25, or 30 degrees to any of about 35, 40, or 45degrees. Accordingly, practitioners may be trained to cannulate a vesselat any of a number of angles that fall within any of the foregoingranges. In various embodiments, the opening 1150 thus can readilyaccommodate any of the angles at which cannulation may proceed withoutbinding of the access device 144. Larger insertion angles can result ina greater range of possible longitudinal positions within the opening1150 through which the access device 144 can be inserted, as previouslydiscussed. However, since many cannulations take place at relativelysmall angles (e.g., about 20 to about 30 degrees), the range of possiblelongitudinal positions is also small.

Moreover, in some instances, the range of possible longitudinalpositions can be a factor primarily with respect to an initial insertionof an access device 114. That is, although the opening 1150 may besufficiently elongated to allow the creation of an insertion site 266 atany of a variety of positions within the longitudinal range, repeateduse of the port 1100 can nevertheless result in only a single insertionsite 266. For example, in an initial access event, the access device 114may be inserted through the opening 1150 at any of a variety of suitablepositions. However, in subsequent access events, surrounding tissue canhelp guide the access device 144 along a path that was traveled by theprevious access device 144 such that the previous insertion site 266into the vessel is used in the subsequent access event. Formation of abuttonhole access site thus may proceed in manners similar to those ofstandard methods.

With reference to FIGS. 22E and 22G, the ingrowth-inducing covering 1152can be recessed at the forward end 1180 of the opening 1150 so as toexpose a lip 1109 of the base 1102. Such an arrangement can also reducebinding of an access device 144.

With reference to FIGS. 22E and 22G, the port 1100 can define afootprint 1168 that has an outermost perimeter 1169. As shown in FIG.22G, a region 1186 of the central axis AX can be vertically even withthe footprint 1168. In the illustrated embodiment, the region 1186 ofthe central axis AX extends a finite distance in the vertical direction,as the footprint 1168, which corresponds with the bottom surface 1108 ofthe base 1102, is bowed. The entirety of the region 1186 is interior tothe outermost perimeter 1169 of the footprint 1168. Moreover, as can beseen by comparing FIG. 22G with FIG. 22F, the entirety of the region1186 is also interior to the peripheral extent 1166 of the port 1100. Asdiscussed below, in other embodiments, at least a portion of the region1186 can be exterior to one or more of the outermost perimeter 1169 ofthe footprint 1168 and the peripheral extent 1166 of the port 1100.

With reference to FIG. 22E, a width WW of the wings 1140 can besignificantly greater than a width WB of the base 1102. For example, invarious embodiments, the width WW can be no less than 1.5, 2.0, or 2.5times greater than the width WB. In some instances, the wings 1140 thewidth WW is greater than a width of a vessel to which the port 1100 isattached. The width WW of the wings 1140 can assist a clinician inholding or steadying the port 1100 during an access event. A height ofthe wings 1140, which also can be significantly greater than a thicknessor height of the base 1102, also can assist in locating, holding, and/orsteadying the port 1100, as discussed further below.

The funnel region 1132 can serve as a target toward which an accessdevice 144 can be directed and, as further discussed below, the funnelregion 1132 can constrain movement of the access device 144 as it isadvanced therethrough. The target-like nature of the funnel region 1132can be particularly helpful where the port 1100 is implanted deeplybelow an outer surface of skin of a patient. A rear plan view targetarea 1187 of the funnel region 1132 can be defined as the area of thefunnel region 1132 that is visible in a two-dimensional projection ofthe port 1100 such as that in FIG. 22C. Similarly, a top plan viewtarget area 1188 of the funnel region 1132 can be defined as the area ofthe funnel region 1132 (exclusive of the opening 1150) that is visiblein a two-dimensional projection of the port 1100 such as that in FIG.22D. In various embodiments, an area defined by the rear plan viewtarget area 1187 can be no less than about 0.25, 0.5, 0.75, 1.0, 1.25,or 1.5 times that defined by the top plan view target area 1188, nogreater than about 0.25, 0.5, 0.75, 1.0, 1.25, or 1.5 times that definedby the top plan view target area 1188, or within a range of from about0.25, 0.5, 0.75, 1.0, or 1.25 to about 1.5 times that defined by the topplan view target area 1188.

With reference to FIG. 22C, because the wings 1140 of the body 1104extend outwardly beyond the base 1102, the rear plan view target area1187 can be relatively large, as compared with arrangements such as thatof the port 500 (see FIG. 16B). Similarly, the top plan view target area1188 can be relatively large. As discussed further below, the rear plantarget area 1187 can be enlarged for ports that are configured for deepimplantation. Such an arrangement can facilitate cannulation of thevessel, due to the increased target size, and also can position thepalpation projection 1146 closer to the surface of the skin when theport is implanted.

FIGS. 23A-23E resemble FIGS. 11A-11E above, and depict variousprocedures that may be performed relative to an implanted vascularaccess port 1100. As with the port 100, the vascular access port 1100can facilitate the creation of a single-site buttonhole. The vascularaccess port 1100 likewise can facilitate use of the buttonhole once itis formed. Many of the features discussed above with respect to FIGS.11A-11E can be similar or identical to uses of the port 1100, and thusmay not be repeated hereafter. Other features and advantages of the port1100 are discussed, some of which may vary from those discussed abovewith respect to FIGS. 11A-11E, while others may be common to both ports100, 1100.

As shown in FIGS. 23A-23E, tissue 217 may grow into, attach to, orotherwise cover various areas of the vascular access port 1100. Forexample, skin tissue may grow into at least a portion of the guidancepassageway 1130. In the illustrated embodiment, tissue covers theentirety of the guidance passageway 130. Accordingly, in the illustratedembodiment, sufficient time has passed between implantation of the port1100 (e.g., via procedures such as those depicted in FIGS. 9A-9E) and afirst access event (depicted in FIG. 23B) to permit growth of the tissue217. In other instances, at least a first such access event may takeplace prior to any or full ingrowth or overgrowth of the tissue 217.

In some instances, a large amount of tissue ingrowth relative to theport 1100, or in further instances, a complete covering of tissue overthe port 1100, can reduce, inhibit, or prevent direct contact betweenthe access device 144 and the port 1100 during an access event. Thetissue 217 thus can act as a barrier between the access device 144 andthe port 1100, which can reduce or eliminate a risk of infection thatmight otherwise arise from contact between the foreign access device 144and the implanted port 1100.

As previously discussed, in some embodiments, the opening 1150 of theport 1100 is relatively large, which can facilitate ingrowth of thetissue into the guidance passageway 1130. The relatively large opening1150 can be significantly longer and/or wider than an outer diameter ofthe access device 144 (see FIG. 23B), which can facilitate insertion ofthe access device 144 without directly contacting the edges of theopening 1150. The large opening 1150 also can serve to inhibit orprevent binding of the access device 144, particularly in the presenceof such ingrowth.

Despite relatively large size of the opening 1150 as compared with anouter diameter of the access device 144, in many embodiments, the port1100 can nevertheless assist in the creation of only a single insertionsite or buttonhole 266 through the wall of the vessel 200. In someembodiments, the guidance passageway 1130 constrains movement of variousaccess devices 140, which may be inserted individually through the port1100 on separate occasions, toward the opening 1150 and along a paththat is directed toward the single insertion site 266. In someembodiments, the constraint may be indirect due to tissue 217 that ispositioned between the port 1100 and the access device 144.

With reference to FIG. 23A, for an initial access event, a clinician 260can palpate an outer surface of the skin 216 to locate and determine theorientation of the vascular access port 1100. In the illustratedembodiment, the clinician 260 is using fingers to contact the skin 216that is positioned above a forward end of the palpation projection 1146.In other instances, the clinician 260 can palpate any other suitableportion of the body 1104 to determine the location (e.g., depth) andorientation of the port 1100. For example, the clinician 260 may use oneor more fingers and/or a thumb to contact the skin 216 that is over orbeside other portions of the palpation projection 1146, or to squeezethe skin 216 that is at either side of the wings 1140. In still other orfurther embodiments, a clinician may visually determine a location andorientation of the port 1100. Prior or subsequent to the stage shown inFIG. 23A, the clinician 260 can clean a surface of the skin with anysuitable antiseptic so as to reduce the risk of introducing pathogensinto the bloodstream of the patient.

FIG. 23B illustrates an embodiment of an access device 144 directlyaccessing a lumen 262 of the vessel 200 via the vascular access port1100 for a first time. In the illustrated embodiment, the fingers of onehand of the clinician 260 remain positioned over the forward end of thepalpation projection 1146 so as to maintain an understanding of theposition of the port 1100 and/or so as to steady the port 1100 duringinsertion of the access device 144 using another hand (not shown). Inother or further instances, continued palpation of the port 1100 maytake place at side regions of the port 1100, such as the wings 1140 andtheir associated portion of the palpation projection 1146. For example,skin on either side of the wings 1140 can be compressed inwardly so asto align and/or steady the port 1100. Continued palpation of the port1100 can aid in achieving a desired alignment of the access device 144with the guidance channel 1130 and/or preventing movement of the port1100 during insertion.

The port 1100 can guide the access device 144 into the vessel 200 inmanners such as previously described. It is also noted that, in sodoing, the port 1100 can protect the vessel 200 from undesiredcannulations. For example, by isolating a small portion of the vessel200 to which a tip of the access device 144 is directed, the port 1100can prevent the tip from contacting other portions of the vessel 200.Thus, as shown in FIG. 23B, the port 1100 not only directs the accessdevice 144 to the opening 1150, but also prevents the access device 144from cannulating the vessel 200 at positions that are forward of,rearward of, and lateral to the opening 1150.

As previously mentioned, some protocols for the creation and use ofbuttonhole cannulation sites can require introduction of a needle into avessel at a designated acute angle. In some embodiments, the angledefined by a central axis AX of the funnel region 1132 (see FIG. 22G)can correspond with this specified angle. In many embodiments, an accessdevice 144 can be inserted through the opening 1150 at any of a widerange of angles without binding, such that exact alignment with thecentral axis AX is not necessary. Moreover, in some embodiments, thecentral axis AX may not necessarily be within the preferred range ofangles. For a first access event, a clinician thus may have a degree ofliberty in introducing the access device 144 at an angle that isconsistent with a desired protocol.

FIG. 23C illustrates a stage of the procedure after removal of theaccess device 144. The insertion site 266 is shown in a closed state, inwhich it is allowed to heal. Prior to closure and healing of theinsertion site 266, however, blood 268 can be permitted to exit thereby,and may fill at least a portion of the guidance passageway 1130. Thepractitioner 260 can apply pressure above the vascular access port 1100to achieve hemostasis. In the illustrated embodiment, pressure fromabove the port 1100 can achieve hemostasis readily easily, as thepressure transfers to the tissue 217 that is directly above the opening1150. Such an arrangement may, in some instances, more readily achievehemostasis, as compared with arrangements such as that illustrated inFIG. 11C. In some embodiments, pressure may be applied for a period ofno more than about 3, 4, 5, 6, 7, 8, 9, or 10 minutes in order toachieve hemostasis.

FIG. 23D depicts the port 1100 after removal of the access device 144therefrom at the completion of an initial access event. Without beinglimited by theory, the insertion site 266 and the insertion tract 264can begin to heal. It may be desirable to conduct another access eventbefore too much time has passed, which would result in the insertionsite 266 completely healing. For example, in various instances, it canbe desirable to allow no more than 2, 3, 4, 5, or 6 days to pass betweenaccess events to ensure that the single insertion site 266 can readilybe used in the latter access event.

FIG. 23E illustrates the use of a blunt-tipped access device 144 for asecond access event—specifically, an access event that is subsequent tothe initial access event depicted in FIG. 23B, where no other accessevents have occurred between the access events depicted in FIGS. 23B and23E. In the illustrated embodiment, the guidance passageway 1130constrains movement of the access device 144 along a path so as todirect a distal tip 149 of the device 144 to the insertion site 266. Theconstrained movement may be indirect, as tissue can cover an interior ofthe guidance passageway 1130. Without being limited by theory, the blunttip 149 can force open the insertion site 266 at a position where thewall was previously cut by the sharp-tipped access device 144 (FIG. 23B)so as to access an interior of the vessel 200. Moreover, use of theblunt-tipped access device 144 may improve the likelihood that accesswill be achieved via the insertion site 266, as the blunt-tipped needlemay be less likely to cut a new insertion site 266 in the vessel wall.

In the illustrated embodiment, a seal can form about the opening 1150due to the ingrowth of tissue into the ingrowth-inducing covering 1152(FIG. 22E). The seal can be hemostatic, so as to inhibit or preventbleeding from the insertion site 266 along a path between the port 1100and the vessel wall. The seal also can inhibit tenting of the vesselwall during insertion of an access device 144 therethrough. In someembodiments, this feature can be particularly useful in creating asingle-site buttonhole 266, such as where blunt-tipped access devices144 are used relatively soon after an initial access event. This mayalso be advantageous where the port 1100 has a relatively larger opening1150, as compared with the size of the access device 144.

FIGS. 24A-24G illustrate another embodiment of a vascular access port1200. A width WW of the vascular access port 1200 can be approximatelythe same as the width WW of the vascular access port 1100 describedabove, but a width WB thereof may be somewhat larger than the width WBof the vascular access port 1100. Accordingly, wings 1240 may extendpast a perimeter 1206 of a base 1202 to a lesser extent than do thewings 1140 of the port 1100. Additionally, a radius of curvature of thebase 1202 can be larger than a radius of curvature of the base 1102. Aheight H of the port 1200 may be approximately the same as the height Hof the port 1100. An opening 1250 of the port 1200 may have the sameconfiguration and dimensions as the opening 1150.

The port 1200 thus can be configured for use with a somewhat largervessel than the port 1100. However, the port 1200 can be implanted in apatient at approximately the same depth as the port 1100 withoutsubstantially changing an observable profile at the surface of the skinof the patient. A funnel region 1232 of the port 1200 can be about thesame size and configuration of the funnel region 1132. For example, thefunnel region 1232 may define a central axis AX that defines the sameangle relative to the base 1202 as the central axis AX of the port 1100does relative to the base 1102.

The port 1200 thus may be configured for use with the same type ofvessel as the port 1100, but with a different patient who may havelarger vessels. By way of example, the port 1100 may be configured foruse with vessels having an outer diameter of approximately 7millimeters, whereas the port 1200 may be configured for use withvessels having an outer diameter of approximately 9 millimeters. Similarmethods for implantation and use thus may be performed for each port1100, 1200.

A system for providing a selection of vascular access ports for a givenuse thus may comprise both of the ports 1100, 1200. For example, adistributor may offer both types of ports 1100, 1200 as alternatives toaccommodate varying needs of a customer, and/or may deliver one or bothports 1100, 1200 to a customer so as to be used with any of a variety ofpatients having differing anatomies. Such systems can include other orfurther ports of differing lengths, heights, base sizes, funnel widths,and/or funnel configurations.

FIGS. 25A-25G illustrate another embodiment of a vascular access port1300. A width WW of the vascular access port 1300 can be approximatelythe same as the width WW of each of the vascular access ports 1100, 1200described above, but a width WB thereof may be somewhat larger than thewidth WB of the vascular access port 1200. Accordingly, wings 1340 mayextend past a perimeter 1306 of a base 1302 to a lesser extent than dothe wings 1240 of the port 1200. Additionally, a radius of curvature ofthe base 1302 can be larger than a radius of curvature of the base 1202.A height H of the port 1300 may be approximately the same as the heightH of the ports 1100, 1200. Other aspects of the port 1300 may be thesame as or similar to those of the ports 1100, 1200.

The port 1300 thus may be configured for use with the same type ofvessel as the ports 1100, 1200 but with a different patient who may haveeven larger vessels. Or the port 1300 may be configured for use with adifferent type of vessel that has a larger diameter but is positionedapproximately the same distance beneath an outer surface of the skin. Byway of example, the ports 1100, 1200 may be configured for use withvessels having outer diameters of approximately 7 and 9 millimeters,respectively, whereas the port 1300 may be configured for use withvessels having an outer diameter of approximately 11 millimeters.Similar methods for implantation and use thus may be performed for eachport 1100, 1200, 1300.

FIGS. 26A-26G illustrate another embodiment of a vascular access port1400, which can resemble the vascular access ports described above incertain respects. The vascular access port 1400 can particularlyresemble the access port 1100, but may be configured for deeperimplantation within a patient. For example, in some embodiments, a widthWB of the base 1402 of the port 1400 is approximately the same as thewidth WB of the base 1102. Similarly, each port 1100, 1400 may define alength L that is approximately the same. However, a height H of the port1400 can be greater than the height H of the port 1100. The height H canbe greater than the width WB of the base 1102. In various embodiments,the height H can be no less than about 1.0, 1.25, 1.5, 1.75, or 2.0times the width WB of the base 1102.

As a result of the greater height H of the port 1400, yet similaritiesbetween the ports 1100, 1400 in other dimensions, the port 1400 maydefine a rear plan view target area 1487 that is significantly largerthan the rear plan view target area 1187 of the port 1100. However, theport 1400 can define a top plan view target area 1488 that isapproximately the same size as the top plan view target area 1188.Depending on how much more deeply the port 1400 is configured forimplantation, as compared with the port 1100, the size of the targetareas 1487, 1488 may be relatively larger or smaller. In variousembodiments, the rear plan view target area 1487 of the port 1400 can beno less than about 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.75, or 2.0 timesgreater than the target area 1187 of the port 1100, and in other orfurther embodiments, the top plan view target area 1488 of the port 1400can be no more than about 1.0, 1.2, 1.3, 1.4, 1.5, 1.6, 1.75, or 2.0times greater than the top plan view target area 1188 of the port 1100.

As can be appreciated from FIG. 26C, in the illustrated embodiment, themaximum width W_(W) of the port 1400, which is defined by wings 1440,can be about the same as the maximum width W_(W) of the port 1100.Similarly, the bottom contour of the rear plan view can be substantiallythe same between the two ports 1100, 1400. However, the wings 1440 ofthe port 1400 can extend upward to a greater height than those of theport 1100, and can slant inwardly. In the illustrated embodiment, thefunnel region 1432 extends transversely outward past the maximum widthWB of the base 1102.

As shown in FIG. 26F, a palpation projection 1446 of the port 1400 canbe more curved or convexly rounded in the longitudinal direction thanthe palpation projection 1146 of the port 1100. As shown in FIG. 26G, aforward face of the funnel region 1432 can be more vertically orientedthan that of the funnel region 1132, whereas a rearward face can be atapproximately the same orientation relative to a base 1402 of the port1400. Accordingly, the forward face of the funnel region 1432 may definea maximum angle r relative to the base 1402, and the rearward face candefine a minimum angle γ relative to the base 402. A central axis AX ofthe funnel region 1432 thus can define a slightly more shallow angle(β′+γ)/2 relative to the base 1402, as compared with the angle (β+γ)/2of the port 1100.

The port 1400 can be configured for use with a somewhat deeper yetsimilarly sized vessel, as compared with the port 1100. By way ofexample, the ports 1100, 1400 may each have a base width WB ofapproximately 7 millimeters, yet the port 1100 may have a height withina range of from about 2 millimeters to about 3 millimeters, while theport 1400 may have a height within a range of from about 4 millimetersto about 5 millimeters. Similar methods for implantation and use may beperformed for each port 1100, 1400.

Similarities and differences such as those just described with respectto the ports 1100, 1400 may also exist between the port 1100 and theport 1500 depicted in FIGS. 27A-27G. In particular, the port 1500 may beconfigured for even deeper implantation, as compared with the port 1100.The port 1500 may have a larger rear plan view target area 1587 thanthat of the port 1400, but may have a top plan view target area 1588that is about the same as that of the port 1400. The port 1500 may havea palpation projection 1546 that is even more curved than that of thepalpation projection 1446. A funnel region 1532 of the port 1500 maydefine a central axis AX that is at the same angle (β′+γ)/2 as that ofthe central axis of the port 1400.

With reference to FIG. 27C, a funnel region 1532 of the port 1500 canextend laterally outward past a maximum base width WB of the port 1500.The rear plan view target area 1587 likewise can extend laterallyoutward past the base width WB. The target area 1587 (which can bedefined by the funnel region 1532) can define a height H_(F) that isgreater than the width of the base WB. Moreover, the target area 1587can extend laterally outward over the base width WB along a portion ofthe height H_(F) that is greater than the width of the base WB. Such anarrangement can be of particular assistance in directing an accessdevice through the port 1500 when the port is implanted deeply within apatient.

In certain embodiments, the base width WB of the port 1500 may beapproximately 7 millimeters, yet the port 1500 may have a height withina range of from about 6 millimeters to about 7 millimeters. Otherdimensions of the ports 1100, 1400, 1500 are also possible. For example,in various embodiments, the base width WB may be within a range of fromabout 5 millimeters to about 15 millimeters, about 6 millimeters toabout 10 millimeters, or no less than about 5, 6, 7, 8, 9, 10, or 11millimeters. In other or further embodiments, the height may be within arange of from about 2 millimeters to about 15 millimeters, about 5millimeters to about 10 millimeters, or no less than about 2, 3, 4, 5,6, 7, 8, 9, 10, 11, 12, 13, 14, or 15 millimeters. Other dimensions arealso possible. Additionally, relationships between the width WB and theheight H for various embodiments of the ports 1100, 1400, 1500 can bethe same as those described above with respect to the port 100.

Similar methods for implantation and use may be performed for each port1100, 1400, 1500. However, as previously mentioned, the ports 1400, 1500can be configured for use with deeper vessels than those with which theport 1100 may be used. The vessels may be positioned so deeply that theycannot be detected by external palpation. Such vessels may be at anative position that is directly below an outer surface of the skin ofthe patient by a distance of no less than about 5, 6, 7, 8, 9, or 10millimeters. The ports 1400, 1500 can be implanted in any suitablemanner, such as those described above with respect to FIGS. 9A-9E and10A-10G. As can be appreciated from the techniques described withrespect to these drawings, the ports 1400, 1500 can be implanted on anysuitable vessel, such as a blood vessel within any suitable limb of apatient. In some embodiments, the vessel is allowed to remain in itsnative position after implantation of the port 1400, 1500, which canprevent complications that might otherwise arise from modification ofthe position of the vessel relative to an outer surface of the skin. Forexample, in certain prior art techniques that are used to make nativelydeep vessels accessible for hemodialysis or other procedures, the deepvessel may be transposed (e.g., moved from a native position beside amuscle to a different position over the muscle) or elevated. In other orfurther prior art procedures, tissue may be removed from the patientsuch that a distance between the vessel and the outer surface of theskin is reduced. Such modification of the relative position between thevessel and the outer surface of the skin may be undesirable, in certaincircumstances. Accordingly, in some cases, it can be desirable toimplant a port 1400, 1500 within the patient without modifying thenative position of the vessel. Once implanted, the port 1400, 1500 canbe externally palpated through the skin so as to determine a locationand orientation of the vessel, and the port 1400, 1500 can otherwise beused in manners such as described above.

In other embodiments, a shorter port (e.g., the port 1100) can be usedwith a vessel that has been modified from its native position relativeto the outer surface of the skin. For example, the port 1100 can be usedwith a vessel that has been transposed or elevated, or one that isrelatively closer to an outer surface of the skin due to removal oftissue from a position between the outer surface and the vessel.Accordingly, in some embodiments, techniques such as those describedwith respect to FIGS. 9A-9E and 10A-10G can be suitably combined withthe prior art techniques of transposition, elevation, or tissue removalso as to achieve such a shallow implantation of the shorter port.

In some embodiments, any suitable port described herein can be used forhemodialysis. In some instances, ports that can be implanted at a deepposition within a patient can be particularly advantageous. For example,some patients may have thick layers of tissue that obscure the locationof their blood vessels so as to prevent the palpation thereof, even atpositions that would allow palpation for other patients. As a furtherexample, some vessels may be readily accessible at the forearm of apatient, but much less accessible in the upper arm. Deep implantationthus can allow for use of vessels, or greater portions thereof, thanwould be possible otherwise.

In some instances, arteriovenous fistulas may be used for suchhemodialysis procedures. Ports such as described above can beparticularly useful with such fistulas, and can allow such fistulas tobe used more effectively. Illustrative examples of such arteriovenousfistulas include fistulas of the radial artery and the cephalic vein,the radial artery and the basilic vein, the ulnar artery and the basilicvein, the brachial artery and the cephalic vein, the brachial artery andthe basilic vein, the brachial artery and the median antecubital vein,the femoral artery and the saphenous vein, and the femoral artery andthe femoral vein.

A system for providing a selection of vascular access ports for a givenuse may comprise any suitable combination of the ports 1100, 1200, 1300,1400, 1500. For example, a distributor may offer two or more of theports 1100, 1200, 1300, 1400, 1500 as alternatives to accommodatevarying needs of a customer (e.g., for differently sized vessels and/orvessels at different depths), and/or the distributor may deliver one ormore of the ports 1100, 1200, 1300, 1400, 1500 to the customer. One ormore of the ports may be used with patients having differing anatomies.

FIGS. 28A-28G illustrate another embodiment of a vascular access port1600, which can resemble the vascular access ports described above incertain respects. The vascular access port 1600 can particularlyresemble the access port 1100, but can have a differently shaped funnelregion 1632. As shown in FIG. 28G, the funnel region 1632 can include abase surface 1638 that defines an angle γ relative to a base 1602 of theport 1600, and can include a backstop portion 1642 that defines an angleβ relative to the base 1602. The backstop portion 1642 can be angledrearwardly such that the angle β is acute. A central axis AX of thefunnel region 1632 thus can be at an angle (β+γ)/2 relative to the base1602 that is more shallow than a similar angle defined by the centralaxis AX of the port 1100.

FIGS. 29A-29G illustrate another embodiment of a vascular access port1700, which can resemble the vascular access ports described above incertain respects. The port 1700 includes a funnel region 1732 that ishigher than the funnel region 1132 of the port 1100, relative to a base1702 of the port 1700. As can be seen in FIG. 29B, the port 1700includes an atrium, chamber, or cavity 1711, which encompasses at leasta portion of an opening 1750 at a distal end of the funnel region 1732.The base 1702 likewise can define an opening 1753 at the bottom end ofthe cavity 1711. In the illustrated embodiment, the cavity 1711 extendsoutwardly and downwardly from the opening 1750. The cavity 1711 can bedefined by a bottom surface 1708 of the port 1700; in particular, thebottom surface 1708 of the port 1700 can extend inwardly from the outeredges of the base 1702, upwardly through the base 1702, and eitheradjacent to or at an interior of a body 1704 of the port. The bottomsurface 1708 of the port 1700 can alternatively be described as asurface that extends outwardly and/or downwardly from the opening 1750to a peripheral edge of the base 1702. As shown in FIG. 29H, the opening1750 can be suspended or elevated relative to the portion of the bottomsurface 1708 that is configured to contact a vessel wall. As shown inFIG. 29F, in some embodiments, the opening 1750 can otherwise resemblethe opening 1150 described above.

In the illustrated embodiment, an ingrowth-inducing covering 1752 isrestricted to the portion of the bottom surface 1708 that will contactthe wall of a vessel, and does not cover an inner surface of the cavity1711. In other embodiments, the cavity 1711 may include aningrowth-inducing covering. As shown in FIG. 29F, the ingrowth-inducingcovering 1752 can fully encompass the opening 1750. In otherembodiments, the ingrowth-inducing covering 1752 may only partiallyencompass the opening 1750. As with other embodiments described herein,ingrowth-inducing features other than a covering or coating arepossible. When the port 1700 is implanted in a patient, tissue mayeventually fill the cavity 1711. A greater space between the bottomsurface 1708 of the port 1700 and a vessel to which it is attachedwithin the cavity 1711 region can allow a more natural healing responseafter access events. For example, the vessel wall may thicken uponformation of button hole site, and such thickening may be accommodatedby the cavity 1711.

FIGS. 30A-30C illustrate another embodiment of a vascular access port1800, which can resemble the vascular access ports described above incertain respects. The port 1800 can include a guidance passageway 1830,which can include a funnel region 1832 and a channel 1834. The channel1834 is situated at a front end of the port 1800. As shown in FIG. 30B,the channel 1834 can have a substantially cylindrical outer profile andcan define a central axis AX that extends through a center of thecylinder. A distal end of the channel 1834 defines an opening 1850. Asshown in FIGS. 30B and 30C, a portion of the distal opening 1850 is at abottom surface 1808 of the port 1800. Another portion of the opening1850 extends upwardly away from the bottom surface 1808. Accordingly,only a portion of the opening 1850 is encompassed by ingrowth-inducingfeatures 1802 that are incorporated into a base 1802 of the port 1800.In particular, attachment passages 1814 and an ingrowth-inducingcovering 1852 extend about only a rearward portion of the opening 1850.

With reference to FIG. 30B, the base 1802 can define a footprint 1868that has an outermost perimeter 1869. Both a body 1804 and the base 1802of the port 1800 can define an outermost periphery 1160 which, whenprojected vertically, defines a peripheral extent 1866 of the port 1800.The central axis AX can have a region 1886 that is vertically even withthe footprint 1868. An upper portion of the region 1886 is interior tothe outermost perimeter 1869 of the footprint 1868. A lower portion ofthe region 1886 is exterior to the outermost perimeter 1869 of thefootprint 1868. However, the entire region 1886 is interior to theperipheral extent 1866 of the port 1800.

FIGS. 31A-31C illustrate another embodiment of a vascular access port1900, which can resemble the vascular access ports described above incertain respects. The port 1900 can include a guidance passageway 1930,which can include a funnel region 1932 and a channel 1934. The channel1934 is situated at a front end of the port 1900. As shown in FIG. 31B,the channel 1934 can have a substantially cylindrical outer profile andcan define a central axis AX that extends through a center of thecylinder. A distal end of the channel 1934 defines an opening 1950. Asshown in FIGS. 31B and 31C, the opening 1950 does not extend to thebottom surface 1908 of the port 1900. Rather, the opening 1950 extendsupwardly so as to be spaced from the bottom surface 1908.Ingrowth-inducing features 1951 that are incorporated into a base 1902of the port 1900 do not encompass the opening 1950. In particular, aningrowth-inducing covering 1952 that is restricted to the bottom surface1908 is spaced rearwardly from the opening 1950. It is also noted thatno portion of the ingrowth-inducing covering is vertically even with theopening 1950. Similarly, all of the attachment passages 1914 arerearward of the opening 1950. It is also noted that only a portion of arearward attachment passage 1914 a is vertically even with a bottom endof the opening 1950, whereas remaining attachment passages 1914 arefully below the opening 1950.

With reference to FIG. 31B, the base 1902 can define a footprint 1968that has an outermost perimeter 1969. Both a body 1904 and the base 1902of the port 1900 can define an outermost periphery 1160 which, whenprojected vertically, defines a peripheral extent 1966 of the port 1900.The central axis AX can have a region 1986 that is vertically even withthe footprint 1968. The entire region 1986 is outside of the outermostperimeter 1969 of the footprint 1968. Moreover, the entire region 1986is exterior to the peripheral extent 1966 of the port 1900.

FIGS. 32A-32C illustrate another embodiment of a vascular access port2000, which can resemble the vascular access ports described above incertain respects. The port 2000 can closely resemble the port 1100discussed above, but can define a much lower profile. The port 2000 caninclude a guidance passageway 2030, which can include a funnel region2032 that narrows toward an opening 2050. As shown in FIG. 32C, abackstop portion 2042 of the funnel region 2032 can be angled forwardlyto a greater extent than the backstop portion 1142 of the port 1100,whereas the base surfaces 1138, 2038 of both ports 1100, 2000 can beabout the same. Accordingly, a central axis AX of the port 2000 candefine a larger acute angle relative to a bottom surface 2008 of a base2002 of the port 2000, as compared with an angle defined by the centralaxis AX of the port 1100.

The port 2000 can include a palpation projection 2046 at an upper end ofthe guidance passageway 2030. As shown in FIG. 32B, the palpationprojection 2046 can substantially define a plane. The substantiallyplanar region defined by the palpation projection 2046 is slightlyconcave in the longitudinal direction at a forward end thereof.

In other embodiments, the backstop portion 1142 may define an evenlarger angle relative to the bottom surface 2008. In still otherembodiments, the funnel region 2032 may be replaced with a substantiallyplanar surface that extends about the opening 2050.

FIGS. 33A-33B illustrate another embodiment of a vascular access port2100, which can resemble the vascular access ports described above incertain respects. The port 2100 can be particularly well-suited forpermitting access to a vessel in either an antegrade or a retrogradedirection (e.g., either a forward or a rearward direction). For example,the port 2100 can be used to create a single insertion site 266 in anartery wall that can be accessed either in an antegrade or retrogradedirection for uptake in a hemodialysis procedure.

The port 2100 can include a guidance passageway 2130, which can includea funnel region 2132 that narrows toward an opening 2150. The opening2150 can be at a bottom surface 2108 of a base 2102 of the port 2100. Inthe illustrated embodiment, a forward portion 2142 of the funnel region2132 is angled forwardly to a greater extent than the backstop portion1142 of the port 1100, and a rear portion 2138 of the funnel region 2132is angled rearwardly so as to define a greater angle than the basesurface 1138 of the port 1100. The forward and rearward portions 2142,2138 rise vertically and outwardly from the opening 2150 toapproximately the same height. Accordingly, in the illustratedembodiment, the port 2100 may just as easily direct an access devicetoward the opening 2150 when the access device is inserted in aforward-to-rearward direction as when the access device is inserted in arearward-to-forward direction. In the illustrated embodiment, a centralaxis AX of the port 2100 can define a substantially perpendicular anglerelative to the bottom surface 2108 of the base 2108 (e.g., (β+γ)/2=90).

Side portions 2138 of the funnel region 2132 can extend to a greatervertical height than either of the forward and rearward portions 2142,2138, which may assist in constraining movement of an access devicetoward the opening 2150. In the illustrated embodiment, the port 2150 issymmetrical about both a lateral-vertical plane through a center thereofas well as a longitudinal-vertical plane through a center thereof.

Other embodiments can have different arrangements. For example, in someembodiments, the port 2100 is asymmetrical about a centrallateral-vertical plane. One of the forward and rearward portions 2142,2138 may, for example, define a different angle relative to the bottomsurface 2108 and/or may extend upwardly to a greater height as comparedwith the other portion. In other or further embodiments, the port 2100similarly may be asymmetrical about a central longitudinal-verticalplane, as the arrangement of one side portion 2139 may vary relative toan opposing side portion 2139.

The port 2100 can include a palpation projection 2146 at an upper end ofthe guidance passageway 2130. As shown in FIG. 33B, the palpationprojection 2146 can substantially define a plane at a central portion ofthe port 2100, but may define substantially concavely rounded portionsat the forward and rearward ends thereof.

FIGS. 34A-34G illustrate another embodiment of a vascular access port2200, which can resemble the vascular access ports described above incertain respects. The vascular access port 2200 can particularlyresemble the access port 1600, and can have a similarly shaped funnelregion 2232. As shown in FIG. 34G, the funnel region 2232 can include abase surface 2238 that defines an angle γ relative to a bottom surfaceof the port 2200, and can include a backstop portion 2242 that definesan angle β relative to the bottom surface of the port 2200. The backstopportion 2242 is angled rearwardly such that the angle β is acute. Acentral axis AX of the funnel region 2232 thus can be at an angle(β+γ)/2 relative to the bottom surface of the port 2200, which is alsoacute.

As shown in FIGS. 34E-34G, the port 2200 can comprise a palpationprojection 2246 that can include an orientation point or region 2248.The orientation region 2248 can be used by a practitioner in determininga location of a center point 2249 of an opening 2250 defined by a base2202 of the port 2200. The orientation region 2248 can comprise anysuitable arrangement or system that can provide location information tothe practitioner. In the illustrated embodiment, the orientation region2248 comprises a center point of the forward-most portion of thepalpation projection 2246. In particular, as seen in FIG. 34E, thepalpation projection 2246, as viewed from above, comprises a thin ridgethat is substantially C-shaped, with the free ends of the C pointingrearward. The forward, center portion of the ridge comprises theorientation region. Accordingly, a practitioner can palpate thepalpation projection 2246 to determine the orientation and location notonly of the port 2200, but also of the orientation region 2248.

As shown in FIG. 34G, the orientation region 2248 of the palpationprojection 2246 is positioned directly above (e.g., vertically over) thecenter point 2249 of the opening 2250. Such an arrangement can provide anatural feel or natural procedural adaptation for a practitioner who maybe accustomed to accessing a vessel without the assistance of a port.For example, practitioners may generally access a vessel by palpatingthe vessel with one or more fingers of a first hand and inserting aneedle or other access device through the skin of the patient using asecond hand such that a tip of the needle enters the vessel at aposition directly beneath the fingers of the first hand. In arrangementssuch as that illustrated in FIG. 34G, a practitioner may palpate theport 2200 at the orientation region 2248, and can insert an accessdevice through the funnel region 2232 and through the center point 2249of the opening into the vessel of the patient to which the port 2200 isattached. The practitioner may be less prone to contact any surfaces ofthe funnel 2232 during an initial insertion event, as the practitionermay naturally aim for the point 2249 when palpating the orientationregion 2248.

In the illustrated embodiment, the orientation region 2248 issubstantially smooth and transitions imperceptibly to other portions ofthe palpation projection 2246. Stated otherwise, the orientation region2248 comprises a portion of the palpation projection 2246 that apractitioner can recognize based on the shape of the palpationprojection 2246 as a whole (e.g., in the illustrated example, theorientation region 2248 is located at the apex of the palpationprojection 2246). In other embodiments, the orientation region 2248 cancomprise one or more bumps, projections, or other features that canassist in providing tactile information to a practitioner. In other orfurther embodiments, the orientation region 2248 may be positioned otherthan directly above the center point 2249 of the opening 2250.

As can be seen in FIG. 34G, in the illustrated embodiment, a forward endof a body 2204 of the port 2200 slopes forwardly and downwardly from thepalpation projection 2246. This portion of the body 2204 can preventtissue that is directly above it from being pressed downwardly so as toseal the opening 2250. Accordingly, in some instances, it can bedesirable to press downwardly on skin that is at or rearward of theorientation region 2248 of the palpation projection 2246 so as to sealthe opening 2250 to achieve hemostasis.

As shown in FIGS. 34C and 34D, the body 2204 of the port 2200 can definea maximum width WW of the port 2200, a maximum width of the base 2202 isdepicted at W_(B), and a height H of the port 2200 is determined as adistance that the port will extend away from a vessel when it isattached to the vessel. As shown in FIGS. 34D and 34E, the port 2200 canalso define a rear plan view target area 2287 and a top plan view targetarea 2288, which resemble the target areas discussed above.

FIGS. 35A-35F, 36A-36F, and 37A-37F illustrate three additionalembodiments of vascular access ports 2300, 2400, 2500, respectively,which can resemble the access port 2200. However, the ports 2300, 2400,2500 can be configured for increasingly deeper implantation within apatient. In some arrangements, the widths WW and W_(B) and thelongitudinal lengths of each of the ports 2200, 2300, 2400, and 2500 canbe substantially the same. However, the heights H of the ports can varyfrom each other. Accordingly, front elevation view profiles of the ports2200, 2300, 2400, and 2500 (i.e., the profiles seen in FIGS. 34C, 35C,36C, 37C, respectively) can vary from each other. In the illustratedembodiments, a lower portion of the front elevation view profiles ofeach of the ports 2300, 2400, 2500 is substantially the same as thefront elevation view profile of the port 2200. However, the bodies 2304,2404, 2504 of each of the ports 2300, 2400, 2500 extend upwardly fromthis common profile to respectively greater extents. Similarly, as seenin FIGS. 34D, 35D, 36D, and 37D, the rear plan view target areas of theports 2200, 2300, 2400, and 2500 can be increasingly larger. Due tosimilarities between the ports 2200, 2300, 2400, and 2500 in theirwidths and lengths, however, the top plan view target areas 2288, 2388,2488, and 2588 defined by these ports each can be approximately the samesize.

Similar to the arrangements discussed above with respect to FIG. 26F,forward faces of respective funnel regions of the ports 2200, 2300,2400, and 2500 can angle upwardly by increasingly greater amounts,whereas rearward faces of the ports can be at approximately the sameangle. Central axes defined by the funnel regions thus may define acuteangles of increasingly greater size relative to the bases 2202, 2302,2402, and 2502.

In various embodiments, the base width WB of the ports 2200, 2300, 2400,2500 may be approximately 7 millimeters, or may be within a range offrom about 6 millimeters to about 8 millimeters. The heights H of theports 2200, 2300, 2400, 2500 can, in some embodiments, be approximately4, 6, 8, and 10 millimeters, respectively, or can be within ranges offrom about 3 to 5 millimeters, from about 5 to 7 millimeters, from about7 to 9 millimeters, or from about 9 to 11 millimeters, respectively.Other sizes and dimensions are also possible, including those discussedabove with respect to other illustrated embodiments.

FIG. 38 illustrates another embodiment of a vascular access port 2600,which can resemble the vascular access ports described above in certainrespects. The vascular access port 2600 can particularly resemble theaccess port 1100, except that a palpation bridge or bar 2647 can extendover a funnel region 2632 defined by the port 2600. The palpation bar2647 can be configured to provide location and orientation informationto a practitioner who palpates the port 2600 when it is implanted. Apalpation projection 2646 thus can extend about at least a forward edgeand side edges of the funnel region 2632, and can also comprise thepalpation bar 2647. The palpation projection 2646 thus can extend overthe funnel region 2632.

In the illustrated embodiment, the palpation bar 2646 extends over arearward end of an opening 2650 defined by the port 2600. In otherembodiments, the palpation bar 2646 may pass over a center of theopening 2650, and thus may provide information regarding the position ofthe center of the opening 2650 that may be used in a natural manner,such as described above with respect to the port 2200. For example, apractitioner can naturally aim for a center of the opening 2650 bypalpating the palpation bar 2646 and inserting an access device into aposition beneath the palpation bar 2646. In still other embodiments, thepalpation bar 2646 may be positioned in other orientations relative tothe opening 2650. Although not shown in FIG. 38, a forward portion ofthe palpation projection 2646 and the palpation bar 2647 can be curvedor radiused so as to prevent damage to surrounding tissue.

The port 2600 can permit hemostasis to be achieved by applying downwardpressure to skin tissue that is above almost any portion of the port2600. Stated otherwise, the palpation bar 2647 may provide less of ahindrance to the formation of hemostasis where skin is pressed downwardat a forward end of the port 2600, as compared with the illustratedembodiment of the port 2200 as discussed above, although hemostasis canbe readily achieved with either port.

As can be appreciated from the foregoing, embodiments of vascular accessports can be sized and dimensioned to reside within a patient andbeneath an outer surface of the skin of the patient. For example, thevascular access ports can be sized to fit between a vessel (e.g., anysuitable artery or vein, such as, for example, the cephalic, basilic,femoral, jugular, or subclavian vein) and the epidermis of an animalsubject.

Moreover, embodiments of one or more vascular access ports can beincluded in various embodiments of kits. For example, in someembodiments, a kit can comprise a vascular access port such as any ofthe ports described above. The kit can further include one or more of:one or more sutures or other attachment devices by which the port can beattached to a vessel, one or more synthetic grafts (which may bepre-attached to the port or separate therefrom), one or more pads ofingrowth-inducing material (which may be pre-attached to the port orseparate therefrom), and one or more additional vascular access ports ofthe same configuration and/or of one or more different configurations(e.g., different size, shape, etc.). For example, in some embodiments,the kit can include multiple ports such that a practitioner can selectone or more of the ports for implantation. In further embodiments, thekit can include ports of different sizes such that the practitioner canfurther select an appropriate port (or appropriate ports) based on theparticular anatomy of a patient and/or on the target location of theport (or ports).

In various embodiments, a kit can include instructions, which may becontained on a separate sheet or card that may accompany one or moreports within a packet or package. The instructions can includedirections for performing any and/or all of the steps or stages of amethod for implanting the port, such as any and/or all of the steps orstages of any of the procedures discussed above. In other or furtherembodiments, the instructions may provide directions for merelyaccessing such directions. For example, the instructions may list a webaddress, a mailing address, and/or a telephone number that can be usedto locate directions for implanting a port using the contents of thekit.

It is noted that while many of the examples provided herein relate tothe use of vascular access ports with blood vessels, this method ofdisclosure is employed for the sake of convenience and efficiency, butshould not be construed as limiting of the types of procedures withwhich embodiments may be used. Indeed, embodiments of the apparatus,methods, and systems disclosed herein can be used with vessels otherthan blood vessels, such as, for example, vessels within thegastrointestinal tract. Accordingly, the term “vessel” is a broad termthat can include any hollow or walled organ or structure of a livingorganism, whether natural or synthetic.

It will be understood by those having skill in the art that changes maybe made to the details of the above-described embodiments withoutdeparting from the underlying principles presented herein. For example,any suitable combination of various embodiments, or the featuresthereof, is contemplated. For example, any of the access ports can beconstructed in a suitable two-component arrangement such as thatdescribed with respect to FIG. 20 and/or may comprise one or moreresorbable materials.

Additional ports and features thereof are described in U.S. patentapplication Ser. No. 12/697,190, titled SUBCUTANEOUS VASCULAR ACCESSPORTS AND RELATED SYSTEMS, METHODS, AND IMPLANTATION FEATURES, filedJan. 29, 2010, which was published as U.S. Patent ApplicationPublication No. 2010/0191191, the entire contents of which are herebyincorporated by reference herein, and are also described in U.S. patentapplication Ser. No. 12/697,192, titled SUBCUTANEOUS VASCULAR ACCESSPORTS AND RELATED SYSTEMS AND METHODS, filed Jan. 29, 2010, which waspublished as U.S. Patent Application Publication No. 2010/0191166, whichwas incorporated by reference above. Moreover, additional ports andfeatures thereof are described in U.S. patent application Ser. No.12/697,167, titled VASCULAR ACCESS PORTS AND RELATED METHODS, filed Jan.29, 2010, which was published as U.S. Patent Application Publication No.2010/0191179, and was also incorporated by reference above. Such portsinclude, for example, the ports 400, 500, 800, 900, 1000, 1100, 1200,1300, 1400, and 1500 in FIGS. 15A-15G, 16A-16G, 19A-19G, 20A-20G,21A-21G, 22A-22G, 23A-23G, 24A-24G, 25A-25G, and 26A-26G of in U.S.Patent Application Publication No. 2010/0191179. Any suitablecombination of such ports and features with those disclosed herein iscontemplated.

Although symmetries are present in the illustrated embodiments, someembodiments may be asymmetrical. For example in some embodiments, aguidance passageway of a vascular access port may extend generally at anangle relative to a vertical-longitudinal plane through the port suchthat a funnel region may more readily receive an access device thereinat one lateral side of the port as opposed to an opposite lateral sidethereof. Such arrangements may be beneficial in some applications wherea port is implanted on a vessel that may more easily be reached from adirection that is not generally aligned with (e.g., nonparallel to) thevessel.

Any methods disclosed herein comprise one or more steps or actions forperforming the described method. The method steps and/or actions may beinterchanged with one another. In other words, unless a specific orderof steps or actions is required for proper operation of the embodiment,the order and/or use of specific steps and/or actions may be modified.

References to approximations are made throughout this specification,such as by use of the terms “about” or “approximately.” For each suchreference, it is to be understood that, in some embodiments, the value,feature, or characteristic may be specified without approximation. Forexample, although it is noted that in various embodiments, the height Hof the vascular access port 100 is no greater than about 2, 3, 4, 5, 6,7, 8, 9, 10, 11, 12, 13, 14, or 15 millimeters, it is understood that insome embodiments, the height H of the vascular access port 100 is nogreater than exactly 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15millimeters. More generally, where qualifiers such as “about,”“substantially,” and “generally” are used, these terms include withintheir scope the qualified words in the absence of their qualifiers. Forexample, where the term “substantially parallel” is recited with respectto a feature, it is understood that in further embodiments, the featurecan have a precisely parallel orientation.

Reference throughout this specification to “an embodiment” or “theembodiment” means that a particular feature, structure or characteristicdescribed in connection with that embodiment is included in at least oneembodiment. Thus, the quoted phrases, or variations thereof, as recitedthroughout this specification are not necessarily all referring to thesame embodiment.

Similarly, it should be appreciated that in the above description ofembodiments, various features are sometimes grouped together in a singleembodiment, figure, or description thereof for the purpose ofstreamlining the disclosure. This method of disclosure, however, is notto be interpreted as reflecting an intention that any claim require morefeatures than those expressly recited in that claim. Rather, as thefollowing claims reflect, inventive aspects lie in a combination offewer than all features of any single foregoing disclosed embodiment.

The claims following this written disclosure are hereby expresslyincorporated into the present written disclosure, with each claimstanding on its own as a separate embodiment. This disclosure includesall permutations of the independent claims with their dependent claims.Moreover, additional embodiments capable of derivation from theindependent and dependent claims that follow are also expresslyincorporated into the present written description. These additionalembodiments are determined by replacing the dependency of a givendependent claim with the phrase “any of the preceding claims up to andincluding claim [x],” where the bracketed term “[x]” is replaced withthe number of the most recently recited independent claim. For example,for the first claim set that begins with independent claim 1, claim 3can depend from either of claims 1 and 2, with these separatedependencies yielding two distinct embodiments; claim 4 can depend fromany one of claim 1, 2, or 3, with these separate dependencies yieldingthree distinct embodiments; claim 5 can depend from any one of claim 1,2, 3, or 4, with these separate dependencies yielding four distinctembodiments; and so on. Similarly, for the second claim set that beginswith independent claim 12, claim 14 can depend from either of claims 12and 13, with these separate dependencies yielding two distinctembodiments; claim 15 can depend from any one of claim 12, 13, or 14,with these separate dependencies yielding three distinct embodiments;claim 16 can depend from any one of claim 12, 13, 14, or 15 with theseseparate dependencies yielding four distinct embodiments; and so on.

Recitation in the claims of the term “first” with respect to a featureor element does not necessarily imply the existence of a second oradditional such feature or element. Elements specifically recited inmeans-plus-function format, if any, are intended to be construed inaccordance with 35 U.S.C. §112 ¶ 6. Embodiments of the invention inwhich an exclusive property or privilege is claimed are defined asfollows.

The invention claimed is:
 1. A vascular access port comprising: a baseconfigured to be attached to a vessel, the base extending in at least alongitudinal direction and a lateral direction that are orthogonal toeach other, wherein at least a portion of the base is configured tocontact the vessel when the base is attached to the vessel, and whereina bottom surface of the base is configured to face a wall of the vessel;an opening that extends through a full thickness of the base and throughthe bottom surface of the base, wherein the opening is devoid of aclosure apparatus, and wherein the portion of the base that borders theopening is non-deformable; and a body that extends in a verticaldirection that is orthogonal to the longitudinal and lateral directions,wherein the body defines at least a portion of a guidance passagewaythat extends to the opening, and wherein the guidance passageway islarger at the proximal end than it is at the distal end.
 2. The port ofclaim 1, wherein the opening defines a maximum length in thelongitudinal direction that is greater than a maximum width in thelateral direction.
 3. The port of claim 2, wherein the maximum length ofthe opening is at least twice as large as the maximum width of theopening.
 4. The port of claim 1, wherein the entire port isnon-deformable.
 5. The port of claim 1, wherein the bottom surface ofthe base is bowed so as to conform to a wall of a vessel when placedthereon.
 6. The port of claim 1, wherein the guidance passagewaycomprises a channel that has a substantially constant cross-sectionalarea.
 7. The port of claim 1, wherein the guidance passageway defines acentral axis that is configured to be at a non-parallel angle relativeto a longitudinal axis of a vessel when the port is attached to thevessel.
 8. The port of claim 1, wherein the base comprises one or moreingrowth-inducing features that encompass at least a portion of theopening.
 9. The port of claim 1, wherein a bottom surface of the basefurther extends in the vertical direction and is bowed so as to be ableto receive a portion of a vessel therein.
 10. A subcutaneouslyimplantable vascular access port comprising: a base configured to bedirectly attached to a vessel, the base extending in at least alongitudinal direction and a lateral direction that are orthogonal toeach other, wherein at least a portion of the base is configured tocontact the vessel when the base is attached thereto; a body extendingaway from the base in at least a vertical direction that is orthogonalto each of the longitudinal and lateral directions, wherein a height ofthe body in the vertical direction is sufficiently small such that theentire port can be implanted subcutaneously in a patient; and a guidancepassageway that is at least partially defined by the body, the guidancepassageway extending from a proximal end to a distal end, wherein thedistal end of the guidance passageway defines an opening in a bottomsurface of the port, wherein the portion of the port that is immediatelyadjacent to the opening is non-deformable such that the openingmaintains a constant configuration when a medical instrument is insertedtherethrough, and wherein an attachment area encompasses at least aportion of the opening.
 11. The port of claim 10, wherein the attachmentarea comprises one or more ingrowth-inducing features that areconfigured to promote ingrowth of natural tissue therein.
 12. The portof claim 11, wherein the one or more ingrowth-inducing features encirclethe opening so as to be configured to create a hemostatic seal about theopening.
 13. The port of claim 11, wherein the one or moreingrowth-inducing features comprise a porous metal covering.
 14. Theport of claim 10, wherein the attachment area comprises a plurality ofattachment passages through which attachment devices can pass.
 15. Theport of claim 10, wherein the opening is located at a bottom surface ofthe base.
 16. The port of claim 10, wherein the opening is encompassedby a cavity and is positioned above a bottom surface of the base. 17.The port of claim 10, wherein the guidance passageway is devoid of aclosure apparatus.
 18. The port of claim 10, wherein the guidancepassageway is rigid.
 19. The port of claim 10, wherein the guidancepassageway is larger at the proximal end than it is at the distal end.20. The port of claim 10, wherein the guidance passageway comprises achannel that has a substantially constant cross-sectional area.
 21. Theport of claim 10, wherein the guidance passageway defines a central axisthat is configured to be at a non-parallel angle relative to alongitudinal axis of a vessel when the port is attached to the vessel.22. A vascular access port comprising: a base configured to be attachedto a vessel, the base extending in at least a longitudinal direction anda lateral direction that are orthogonal to each other, wherein at leasta portion of the base defines a footprint of the port at which the portcontacts the vessel when the base is attached to the vessel; a bodyextending away from the base in at least a vertical direction that isorthogonal to each of the longitudinal and lateral directions, wherein aheight of the body in the vertical direction is sufficiently small suchthat the entire port remains beneath an outer surface of skin after theport has been implanted in a patient; and a guidance passageway that isat least partially defined by the body, the guidance passagewaycomprising a proximal end and a distal end and defining a central axisthat passes through the proximal and distal ends, wherein the guidancepassageway is configured to direct an access device into a lumen of avessel when the port is attached to the vessel, and wherein, when theport is attached to the vessel, the central axis is non-perpendicularand non-parallel to a longitudinal axis of the vessel.
 23. The port ofclaim 22, wherein the guidance passageway is configured to constrainmovement of the access device so as to align a central axis of theaccess device with the central axis of the guidance passageway when theaccess device is advanced through the guidance passageway.
 24. The portof claim 22, wherein at least a portion of the guidance passagewaydefines a closed loop such that at least a portion of the guidancepassageway fully encircles an access device when the access device isadvanced therethrough.
 25. The port of claim 22, wherein one or more ofthe body and the base define an outermost periphery of the port in thelongitudinal and lateral directions that, when projected vertically,define a peripheral extent of the port, and wherein at least a portionof a region of the central axis that is vertically even with thefootprint is interior to the peripheral extent of the port.
 26. The portof claim 25, wherein said at least a portion of the region of thecentral axis that is vertically even with the footprint is interior toan outermost perimeter defined by the footprint.
 27. The port of claim22, wherein one or more of the body and the base define an outermostperiphery of the port in the longitudinal and lateral directions that,when projected vertically, defines a peripheral extent of the port, andwherein a region of the central axis that is vertically even with atleast a portion of the footprint is outside of the peripheral extent ofthe port.
 28. The port of claim 22, wherein no change to a size or ashape of the port is effected when an access device is advanced throughthe guidance passageway.
 29. The port of claim 22, wherein the distalend of the guidance passageway terminates at an opening, and wherein atleast a portion of the opening is defined by a bottom surface of thebase.
 30. A vascular access port comprising: a base configured to beattached to a vessel, the base extending in at least a longitudinaldirection and a lateral direction that are orthogonal to each other,wherein at least a portion of the base is configured to contact thevessel when the base is attached to the vessel; a body extending awayfrom the base in at least a vertical direction that is orthogonal toeach of the longitudinal and lateral directions, wherein a height of thebody in the vertical direction is sufficiently small such that theentire port can be implanted subcutaneously in a patient; and a guidancepassageway that is at least partially defined by the body and isconfigured to direct an access device into a vessel of a patient whenthe port is attached to the vessel, wherein the guidance passagewaycomprises a proximal end and a distal end and defines a central axisthat is non-vertical and nonparallel to the longitudinal direction suchthat when the base is attached to a vessel, the central axis is at anon-perpendicular and nonparallel angle relative to a longitudinal axisof the vessel, and wherein the guidance passageway is devoid of aclosure apparatus.
 31. The port of claim 30, wherein the distal end ofthe guidance passageway defines an opening, and wherein at least aportion of the opening is at a bottom surface of the base such that theopening is adjacent to a wall of a vessel when the base is attached tothe vessel.
 32. A vascular access port comprising: a base configured tobe attached to a vessel, the base extending in at least a longitudinaldirection and a lateral direction that are orthogonal to each other,wherein at least a portion of the base is configured to contact thevessel when the base is attached to the vessel, and wherein a bottomsurface of the base is configured to face a wall of the vessel; a bodyextending away from the base in at least a vertical direction that isorthogonal to each of the longitudinal and lateral directions, wherein aheight of the body in the vertical direction is sufficiently small topermit the entire port to remain beneath an outer surface of skin afterthe port has been implanted in a patient; and a guidance passageway thatis at least partially defined by the body, the guidance passagewaycomprising a funnel region that decreases in size from a proximal end ofthe guidance passageway toward a distal end of the guidance passageway,wherein the distal end of the guidance passageway defines an opening atthe bottom surface of the port.
 33. The port of claim 32, wherein amaximum length of the opening in the longitudinal direction is greaterthan a maximum width of the opening in the lateral direction.
 34. Theport of claim 33, wherein the length is at least two times as great asthe width.
 35. The port of claim 32, wherein a forward end of theopening is semicircular and sides of the opening that extend from theforward end define straight lines.
 36. The port of claim 32, wherein aforward portion of the funnel region extends vertically upward to agreater extent than does a rearward portion of the funnel region. 37.The port of claim 36, wherein the forward portion of the funnel regionis angled forwardly.
 38. The port of claim 37, wherein the forwardportion of the funnel region defines a backstop portion that isconfigured to assist in directing an access device toward the openingwhen the access device is inserted into the port in arearward-to-forward direction.
 39. The port of claim 36, wherein theforward portion of the funnel region is angled rearwardly.
 40. The portof claim 36, wherein side portions of the funnel region that extendbetween the forward and rearward portions are angled outwardly such thata width of the funnel region in the lateral direction decreases towardthe opening.
 41. The port of claim 36, further comprising a palpationprojection at an upper end of the funnel region that extends from theforward portion of the funnel region to the rearward portion of thefunnel region.
 42. The port of claim 32, wherein the guidance passagewaydefines a rearwardly angled central axis that extends through theopening.
 43. The port of claim 32, wherein a forward portion of thefunnel region is angled forwardly and a rearward portion of the funnelregion is angled rearwardly, and wherein the forward and rearwardportions extend upwardly to approximately the same height such that thefunnel region can just as easily direct an access device toward theopening when the access device is inserted in a rearward-to-forwarddirection as when the access device is inserted in a forward-to-rearwarddirection.
 44. The port of claim 43, wherein side portions of the funnelregion that extend between the forward and rearward portions are angledoutwardly such that a width of the funnel region in the lateraldirection decreases toward the opening.
 45. The port of claim 43,wherein side portions of the funnel region that extend between theforward and rearward portions extend to a greater vertical height thando either of the forward and rearward portions.
 46. The port of claim32, wherein the funnel region is symmetrical about alongitudinal-vertical plane.
 47. The port of claim 46, wherein thefunnel region is symmetrical about a lateral-vertical plane.
 48. Theport of claim 32, wherein the guidance passageway defines a central axisthat is perpendicular to the longitudinal direction.
 49. The port ofclaim 32, wherein at least a portion of the opening is defined by abottom surface of the base.
 50. The port of claim 49, wherein the entireopening is defined by the bottom surface of the base such that theentire opening is at a surface of a vessel wall when the port isattached to the vessel.
 51. The port of claim 50, wherein the basecomprises one or more ingrowth-inducing features that encompass at leasta portion of the opening.
 52. The port of claim 32, wherein at least aportion of the opening is encompassed by a cavity such that the openingis elevated relative to a bottom surface of the base.
 53. A vascularaccess port comprising: a base configured to be attached to a vessel,the base extending in at least a longitudinal direction and a lateraldirection that are orthogonal to each other, wherein at least a portionof the base is configured to contact the vessel when the base isattached to the vessel, and wherein a bottom surface of the base isconfigured to face a wall of the vessel; and an opening that extendsthrough a full thickness of the base and through the bottom surface ofthe base, wherein the opening is devoid of a closure apparatus, andwherein the portion of the base that borders the opening isnon-deformable, and wherein the opening defines a maximum length in thelongitudinal direction that is greater than a maximum width in thelateral direction.
 54. The port of claim 53, wherein the maximum lengthof the opening is at least twice as large as the maximum width of theopening.
 55. A vascular access port comprising: a base configured to beattached to a vessel, the base extending in at least a longitudinaldirection and a lateral direction that are orthogonal to each other,wherein at least a portion of the base is configured to contact thevessel when the base is attached to the vessel, and wherein a bottomsurface of the base is configured to face a wall of the vessel; and anopening that extends through a full thickness of the base and throughthe bottom surface of the base, wherein the opening is devoid of aclosure apparatus, and wherein the portion of the base that borders theopening is non-deformable, wherein the entire port is non-deformable.